Associate Director, Biostatistics Resume Samples

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R Kuhlman

Rocky

Kuhlman

522 Brekke Greens

Boston

+1 (555) 506 9354

522 Brekke Greens

Boston

Phone

p +1 (555) 506 9354

Experience Experience

Houston, TX

Associate Director Biostatistics

Houston, TX

Schulist, Gerlach and Corkery

Houston, TX

Associate Director Biostatistics

Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict. Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies
Serve as departmental representative on division or corporate-wide teams. Advocate application of statistical thinking in decision-making. Work effectively with leaders in other functional areas. Effective corporate use of statistical thinking. Efficient processes in clinical development and operations
Developing Study Quality Surveillance Plan and monitoring study conduct to proactively address issues to ensure high quality study data. Conducting sensitivity analysis that addresses missing data issues in longitudinal studies
Provide statistical input to the overall development of a clinical program, including Lifecycle Management planning and updating Clinical Development Plan
Developing and maintaining SOPs, SWPs and work guidelines and other related technical documents
Interact with senior management to report on project or program milestones
Plan and execute statistical review of clinical publications and other communications

Phoenix, AZ

Associate Director, Biostatistics

Phoenix, AZ

Feil-Franecki

Phoenix, AZ

Associate Director, Biostatistics

Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies, including time-to-event and recurrent event analysis, count and categorical data analysis, longitudinal data analysis (e.g. LME, GEE), missing data methods, nonparametric methods, responder and treatment failure analyses, data-mining techniques, meta-analysis, composite endpoints, etc
Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies, including composite endpoints, time-to-event and recurrent event analysis, binary, count and categorical data analysis, longitudinal data analysis (e.g. LME, GEE), missing data methods, nonparametric methods, ANCOVA, responder and treatment failure analyses, data-mining techniques, meta-analysis, etc
Be a scientific leader/expert within Oncology, showing leadership / be the point of reference in statistical methods, regulatory guidelines, and clinical pharmacology and exposure-response analyses
Manage operationally and functionally, and supervise statisticians (as assigned) including setting objectives, performance management and pro-fessional development activities
Be a core member of an OQC for at most one product. Work within the OQC to formulate a plan for CP and exposure-response analyses that inform decisions-making for the GPT and align with the Clinical Development Plan
Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
Perform vendor qualification / audits in collaboration with functional management

present

Detroit, MI

Director / Associate Director, Biostatistics

Detroit, MI

Waelchi-Douglas

present

Detroit, MI

Director / Associate Director, Biostatistics

present

Set and manage biostatistics project timelines within Ironwood product development programs
Contribute to the development of clinical trial processes that adhere to GXP principles and best practices
Contribute to analysis and reporting standards, and worktools that facilitate the implementation of standards
Promote and integrate statistical methods into Ironwood product development programs
Provide comprehensive status updates to department and project team members
Demonstrated proficiency initiating and managing clinical trials as well as outsourcing trials and programs
Ensure that protocols and statistical analysis plans are followed throughout the course of analysis and reporting - documenting assumptions, decisions, changes, and conclusions

Education Education

Bachelor’s Degree in Biostatistics

Georgia Southern University

Bachelor’s Degree in Biostatistics

Skills Skills

Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
Excellent verbal and written communication and interpersonal skills
Ability to contribute to the preparation of scientific manuscripts
Ability to communicate statistical interpretation to non-scientists
Ability to work in a collaborative environment, drive to learn and improve skills
Participate in vendor selection, and provide oversight function on biostatistics activities and associated deliverables for outsourced clinical studies
Excellent analytical, problem solving, communication and organization skills
Working knowledge of SAS, STATA, R, and other graphics packages
Good communication skills
Demonstrated ability to work in a team environment

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Associate Director, Biostatistics Resume Examples & Samples

A minimum of a Ph.D. in Statistics or related field with minimum 6 years relevant experience
A track record for suggesting, evaluating and implementing successful alternative or innovative approaches to statistical methods or business processes is required
Interaction with clinicians, biologists, other statisticians, information technology colleagues, and Neuroscience management in particular will be a routine, therefore a strong record of written and verbal communication skills are required
Experience of statistics application to drug discovery is preferred
Understanding of the fundamentals of machine learning and the development of predictive models derived from signal feature reduction is preferred
Experience in feature selection from biomedical images is preferred
Experience developing and applying signal processing algorithms is preferred
Proficiency of R or SAS statistical software is required
Knowledge of Matlab is preferred
Knowledge of linear and nonlinear mixed models and multivariate analysis is required
Exposure to modern data analysis techniques such as data visualization, robust statistics and analysis of high-dimensional data is preferred
Experience working autonomously and with cross functional teams is required
Demonstrated people management experience is preferred
10% or less domestic and international travel is required.Biostatistics

Associate Director, Biostatistics Resume Examples & Samples

Be a core member of an OQC for at most one product. Work within the OQC to formulate a plan for CP and exposure-response analyses that inform decisions-making for the GPT and align with the Clinical Development Plan
Be a scientific leader/expert within Oncology, showing leadership / be the point of reference in statistical methods, regulatory guidelines, and clinical pharmacology and exposure-response analyses
Ensure the quality of CP statistical input, and exposure-response analyses integrating expertise across different functions in the OQC (e.g CP, Modeling and Simulation), as well as from external statistical experts, into the CP strategy. Initiate and drive innovation by implementing novel methods and innovative designs to input into and support project strategy. Accountable for CP line function review of CP Biostatistics delivera-bles throughout the project
Manage operationally and functionally, and supervise statisticians (as assigned) including setting objectives, performance management and pro-fessional development activities
Plan, prioritize and track CP activities across projects. Effectively assess and allocate resources, coordinate with CP CDRR and Data Manage-ment
Establish and maintain CP standards, while implementing/championing organization-wide standards
Plan and manage submission activities for all CP aspects, including Summary Clin Pharm, Health Authority responses and Briefing Books
Lead and/or support functional or cross-functional initiatives as needed, including project planning, budget planning, goal setting, effective utili-zation of team diversity and obtaining appropriate commitment
Interact with Health Authorities and external consultants as appropriate. Support and defend statistical/modeling methodology and/or anal-yses/simulations and their use/interpretation at Health Authority Meetings
Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings
Contribute to the assessment and preparation of in-licensing opportunities
Master Degree in Statistics (or equivalent degree) with at least 9-12 years of relevant experience Experience in all tasks of a Lead Statistician (about 5 to 7 years), including submission and significant Health Authority experience
Strong knowledge and expertise in statistics and its application to clinical trials (preferably Oncology); able to explain statistical designs and concepts
Expert knowledge and experience in drug development process (preferably in Oncology), Clinical Pharmacology, HA guidelines and submissions
Record of successful implementation of novel methods and/or innovative strategies
Knowledge of statistical software packages (e.g. SAS, R)
Very good communication and presentation skills. Ability to influence and communicate across functions
Proven strong leadership and project management skills. Demonstrated ability to have managed functional/multi-functional teams and/or initiatives. Good coaching and mentoring skills
Good team player. Good business ethics
Fluent English (oral and written)

Associate Director, Biostatistics Resume Examples & Samples

Directs/oversees the statistical and programming support activities (performed primarily through vendors) for Akebia clinical studies and ensures optimal clinical trial designs and statistical analysis methods
Ensure all study and project level statistical and programming activities are conducted using high quality standards and ensure consistency of statistical and programming approaches utilized
Accountable for the timely production and accuracy of all statistical analyses, programmed outputs and integrated scientific reports for clinical trial results, exploratory analyses, publication activities, scientific presentations, and promotional materials
Participate in vendor selection, and provide oversight function on biostatistics activities and associated deliverables for outsourced clinical studies
Oversee the creation of statistical sections of protocols and statistical analysis plans, contributes to the design of data capture methods (CRFs, other), and participate in development of clinical study reports
Respond to data requests from company team members providing statistical analysis output for ad-hoc and exploratory analyses
Statistical support of pre-clinical and developmental research activities
Oversee the preparation for data monitoring and data review meetings
Develop statistical processes and reporting standards, including but not limited to 1) review of tables / listings / figures, 2) confirm CDISC / CDASH labeling of datasets has occurred, etc
Participate as content expert on cross-functional development teams
Provide input into all relevant submissions, including briefing documents that will be sent to regulatory authorities and participate in regulatory agency meetings, as needed
Strong programming skills with common statistical software packages such as SAS®, S-Plus, PASS, nQuery advisor, EAST
Thorough knowledge of industry standards, as well as ICH, EMEA and FDA guidelines and regulations on clinical trials, statistics, and data management, with a solid understanding on how to apply best practices for analysis and reporting activities, study designs, and statistical methods
Demonstrated ability to work independently and strong leadership skills
Strong problem solving skills, as well as excellent verbal and written communication skills
Superior presentation skills, and the proven ability to work in a team setting

Associate Director, Biostatistics Resume Examples & Samples

Participate in study design and protocol development and ensure that study designs are consistent with study objectives and are optimal within study constraints
Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timing for various scenarios
Propose methods for statistical analysis and write the statistical section of study protocols
Knowledgeable about current important statistical issues in clinical trial study design
Review and consult on CRF design and database edit checks in addition to reviewing programming plans
Prepare randomization schedules
Prepare/review statistical analysis plans, specifications for analysis datasets, and table shells. Ensure that tables, listings, and graphs address the objectives of the study
Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary
Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data
Lead the study and/or project teams in the review and discussion of statistical analysis plans
Interpret statistical results and present study findings to the study teams, senior management, and in various external forums
Maintain project files that ensure adequate and documentation of statistical analyses
Reporting directly to the Director/Sr. Director, Biostatistics within Avanir R&D Operations Department
8+ years of Biostatistics experience in a drug-development environment
5+ years of managing experience in a drug-development environment
Prior experience interacting with health authorities in the United States and/or the EU
Prior experience with IND/BLA/NDA/MAA submissions
Experience or training with a range of skills including SAS programming and other relevant software applications, statistical methodology and theories, and analysis
Experience within a team environment, have strong presentation skills, collaborative skills, negotiation skills and demonstrate self-motivation
Ability to manage multiple and diverse issues
Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel
Experience writing technical and management documents, reports and presentations

Associate Director, Biostatistics Resume Examples & Samples

Broad and thorough understanding of statistical principles and clinical trial methodology, and the ability to practice and implement them
Ability to develop innovative/creative statistical/technical solutions to complex problems
Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas
Able to write and present information effectively
Conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software
Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc

Associate Director Biostatistics Resume Examples & Samples

PhD in statistics or biostatistics
Minimum 7 years relevant experience in the pharmaceutical industry
Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation
Strong analytical and problem solving skills and able to provide guidance to lower level biostatisticians in solving problems
Able to identify and investigate issues and causes independently and formulate potential solutions
Able to develop and execute strategic plans for drug or non-drug projects
Able to prioritize multiple tasks, develop instructions and manage vendors in completing the deliverables with high quality according to timelines, and provide recommendations to improve process
Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes
Excellent programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc
Working knowledge of clinical trial methodologies

Associate Director, Biostatistics Resume Examples & Samples

11+ years of industry experience in the statistical analysis of biomedical data using SAS® software and a BS degree in Biostatistics or equivalent
7+ years of industry experience in the statistical analysis of biomedical data using SAS® software and an MS degree in Biology, Biostatistics or equivalent
5+ year of industry experience in the statistical analysis of biomedical data using SAS® software and a PhD degree in Biostatistics or equivalent

Associate Director Biostatistics Resume Examples & Samples

Demonstrated knowledge of general HR policies and management
Demonstrated leadership, project management, and interpersonal skills
Excellent verbal, writing, and presentation skills
Experience managing direct reports, assembling teams, and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
Ability to recruit, retain, motivate, and develop highly qualified persons; projects and reinforces corporate values
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Innovatively applies technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
In-depth understanding of the regulatory drug submission / approval process regionally and globally
Ability to effectively represent Biostatistics and Programming in multidisciplinary or cross-functional meetings
Sought out for advice by others at senior levels
Ability to work in a fully self-directed manner
Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project. Statistically valid CDP involving one or more studies designed to lead to a key decision point or submission. CDP, related protocols, and statistical analysis plans (SAP) consistent with overall project objectives. CDPs have degree of optimality in terms of timing, use of resources, and probability of success
Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve key results memos and statistical conclusions. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions. Statistical deliverables consistently compliant, in timing and quality, with SOPs and departmental standards
Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with Sanofi-Aventis standard data models, e.g. CIDSC
Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation
Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict. Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies
Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Within area of control, update procedures or practices as needed to remain in compliance. Procedures and practices meet industry standards and are consistent with internal SOP
Serve as departmental representative on division or corporate-wide teams. Advocate application of statistical thinking in decision-making. Work effectively with leaders in other functional areas. Effective corporate use of statistical thinking. Efficient processes in clinical development and operations
Knowledge of regulatory laws / procedures outside of US and Europe
Leadership role in societies or committees relevant to drug development or statistics
Ability to contribute to advancement of statistical or applied specialized area of knowledge

Associate Director, Biostatistics Resume Examples & Samples

Provide consultation, input and guidance to cross-functional groups charged with data mining and lifecycle management projects/studies
Understand existing studies, datasets and analyses well enough to inform team members and guide strategy for future analyses. Harmonize statistical strategies and methods across departments
Provide consultation, input and guidance to cross-functional groups charged with development and submission of manuscripts, posters, slide presentations and abstracts
Design, conduct, QC and report on agreed upon analyses. This includes developing analysis specifications/plans, performing hands-on statistical programming and/or supervising external contractors doing such analysis and programming. Analyses might be pre-planned or post-hoc, hypothesis testing or hypothesis generating, intended for dissemination or exploratory. Present and/or explain findings to team members, internal managers, and/or external authors and experts. Validate inferences. Help craft listings and tables needed for abstracts, posters, slide decks, and manuscripts
Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, colleagues in affiliate countries around the world, external medical writers, and external experts and authors
Work with Publication Leads and team members to respond in a timely manner to journal editor and reviewer comments
Review draft abstracts and manuscripts according to deadlines, and when appropriate, serve as an Author. In some cases, develop abstracts in close collaboration with external medical writers. Serve as group’s expert on Methods sections
Depending on resource needs, assign tasks and supervise the work of external contract statisticians and programmers
Review draft presentations and training materials, including posters and slide decks, according to deadlines
Assist the Head of Biostatistics when requested in any of his/her job responsibilities
As needed, develop Statistical Analysis Plans (SAPs); perform sample size calculations, and feasibility determinations for Phase 4 and HEOR studies upon request. Take lead role for stats sections of Phase 4 protocols as needed. Consult regarding primary and secondary endpoints as per medical strategy. Review protocols and SAPs from Investigator-sponsored Studies upon request
Maintain expertise in current statistical methods and standards relevant to pharma and biotech industry applications
Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies, including time-to-event and recurrent event analysis, count and categorical data analysis, longitudinal data analysis (e.g. LME, GEE), missing data methods, nonparametric methods, responder and treatment failure analyses, data-mining techniques, meta-analysis, composite endpoints, etc
Thorough and up-to-date working knowledge of SAS and S-PLUS (or R). Hands-on Programming experience
Excellent interpersonal skills, negotiation skills, and verbal and written communications
Collaborative approach. Ability to thrive in a fast-paced team environment, and also work independently on projects
Ability to manage effectively one’s projects and quickly accommodate to changing priorities, and also to meet tight deadlines while maintaining high quality standards
Ability to explain strategies, approaches, methods, analyses, and findings to non-statistician group members and senior managers. Ability to help others interpret results and place in context
PhD in Biostatistics or Statistics and 7 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 5 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO) OR
Master’s degree in Biostatistics or Statistics and 10 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 8 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO)
Experience in medical affairs activities
Experience in reporting data on multiple long term extension studies
Specific knowledge and experience in analysis plans and techniques to support approved products in competitive markets
Experience analyzing data from Multiple Sclerosis studies
Experience publishing results
Experience working with external service providers, including project management, vendor management and budget process

Associate Director, Biostatistics Resume Examples & Samples

Provides specification and reviews draft randomization schedules. Primary SAP author. Determines and provides appropriate sample size calculations for specific objectives of study design
Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations
Reviews regulatory documents such as CSRs, as well as summary documents
Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs
Leads or contributes to departmental process improvement initiatives and development/revision of SOPs
Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs
Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs
Direct regulatory filing experience is required
Proficiency in SAS is strongly preferred
Ability to help others understand the broader business and organizational context (inspiring and motivating others)
Demonstrates a customer focus by partnering with customers as a trusted consultant and serves as an integral part of customer’s decision-making process (serving customers)
Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
Ability to determine appropriate designs and analyses for clinical trials
Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed

Associate Director, Biostatistics Immunology Resume Examples & Samples

Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; provides input into clinical development plans
Reviews statistical outputs. Primary author of the statistical methodology section(s) of study reports for study and integrated reports
Consults with the Medical Writer and Physician on the interpretation of efficacy results
Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers
M.S. in Biostatistics or closely related field is required
Ph.D. in Biostatistics or closely related field is strongly preferred
Generally has 8+ years of relevant pharmaceutical experience
Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices
Must have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMEA)
Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
Ability to respond to regulator’s inquiries for products undergoing registration and approved products
Some domestic and international travel required

Associate Director, Biostatistics Resume Examples & Samples

A PhD in Statistics or related field with at least 6 years of experience in the pharmaceutical industry is required
Excellent analytical skills and knowledge of statistical methodology are required
Excellent project management skills are required
Up to 10% travel is required.Biostatistics

Associate Director, Biostatistics Resume Examples & Samples

Lead and manage team of internal and external biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage assignments and priorities of team members
Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents
Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions
Leverage standardization to maximize global data integration and interpretability
Provide statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions and follow up
Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA or other worldwide regulatory agencies
Apply innovative statistical approaches to the design of studies and to the analysis/reporting of study results (e.g., modeling and simulation, adaptive design and /or Bayesian approaches)
Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines
A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience
Comprehensive knowledge of statistical methodology in design and analysis of clinical trials including Bayesian modeling and adaptive design
Regulatory requirements relating to clinical development of drugs and biologics
BLA/NDA experience including eCTD submissions
Working knowledge of major statistical software programs including SAS
Knowledge of CDISC requirements for SDTM and ADaM
Excellent verbal and written communication skills, and excellent inter-personal skills
The qualified applicant must also be flexible, well-organized, and have the ability to work well under pressure

Associate Director Biostatistics Resume Examples & Samples

Provide statistical input to the overall development of a clinical program, including Lifecycle Management planning and updating Clinical Development Plan
Provide statistical input to clinical study design and the interpretation of results
Manage the work of outsourcing partners and vendors at the study and program level, ensuring the timeliness and quality of all statistical deliverables
Author statistical analysis plans as well as relevant sections of protocols, clinical study reports, marketing applications, and other development documents
Support planning for, and submission of, global marketing applications
Plan and execute statistical review of clinical publications and other communications
Interact with senior management to report on project or program milestones
Remain apprised on current statistical literature
PhD in statistics or related field with 7+ years of experience (or MS with 9+ years of experience) in pharmaceutical drug development
Oncology experience is strongly preferred. Cardiovascular experience a plus
Excellent understanding of FDA/EMA guidances and ICH guidelines
Previous experience in interactions with health authorities
Prior submission experience, preferably in both US and ex-US regions
Prior experience in preparing for advisory committee meetings (ODAC, SAG-O) preferred
Good working knowledge of SAS and R
Demonstrated ability to work both independently and in a cross-functional team setting
Strong written and oral communication skills with the ability to effectively influence at all levels of the organization and across all functions
Effective time-management skills that facilitate working on multiple projects

Associate Director, Biostatistics Resume Examples & Samples

Lead, develop, and coordinate biostatistical and statistical programming activities for Clinical Development & Operations, Medical Affairs, and Business Development
Provide statistical expertise and leadership to ensure program objectives are in alignment with regulatory and commercial needs
Collaborate with project management, regulatory, medical affairs, PV/safety, business development, and commercial functions
Contribute to strategic planning and go/no go decision guidance
Participate in vendor selection for biostatistics, statistical programming, data management, interactive response technology (IxRS), and other services wherein data storage and analysis may be applicable; manage and oversee biostatistics and statistical programming tasks
Interact with regulatory agencies and respond to requests as appropriate
Participate in or manage Biometrics participation in risk-based monitoring plans and activities
Ensure timeliness and quality of deliverables
Travel as needed to execute assigned responsibilities and tasks
PhD in statistics or related field and at least 5 years of industry experience or MS in statistics or related field and at least 8 years of industry experience
Professional, proactive demeanor
Experience with people management and development of staff
Excellent interpersonal and project management skills
Comprehensive knowledge of clinical trials methodology, regulatory requirements, and statistical software packages. Experience with interventional, observational and retrospective studies. Ability to contribute strategically
Able to collaborate effectively with internal and external study management teams to meet project timelines
Must be solution-oriented and willing to educate study team members in appropriate interpretation of designs and results

Director / Associate Director, Biostatistics Resume Examples & Samples

Evaluate information from the statistical literature, government agencies, and outside experts relevant to assigned projects and special topics
Act as statistical liaison to FDA/regulatory agencies
Contribute to the development of clinical trial processes that adhere to GXP principles and best practices
Promote and integrate statistical methods into Ironwood product development programs
Serve as statistical liaison with CROs and third party data vendors
Review and approve clinical protocols and clinical study reports including authorship of key sections (sample size, methods, missing data, etc.) and conclusions
Ensure that protocols and statistical analysis plans are followed throughout the course of analysis and reporting - documenting assumptions, decisions, changes, and conclusions
Set and manage biostatistics project timelines within Ironwood product development programs
Provide comprehensive status updates to department and project team members
Contribute to analysis and reporting standards, and worktools that facilitate the implementation of standards
Follow and enhance quality system applicable to best statistical practices and FDA expectations per ICH guidance (e.g., author and update SOPs, as requested by Data Science management)

Manager / Associate Director, Biostatistics Resume Examples & Samples

Serves as principal biometry contact to the clinical development department, providing inputs into clinical trial design and execution, coordinating statistical analysis, reporting, and interpreting the clinical trial results
Analyzes clinical trial data, producing accurate results representing the outcome of the trial. Validates statistical output. Interprets and clearly communicates statistical results and concepts
Supervises the biostatistics work provided by CROs and independent consultants and reviews data management documents including, but not limited to, CRFs, data management plan, database specifications, and edit checks
Uses appropriate statistical methods to estimate the number of patients required for each potential study
Writes Statistical Analysis Plans; prepares for blinded data review meetings
Writes statistical analysis section of protocol and clinical study reports
Oversees the process of randomization schedule generation
Provides input into statistical SOPs and general standardization efforts within the clinical development department (e.g. statistical methodology standards, standard data presentations, standard CRFs)
Supports Regulatory Authority meetings (e.g. pre IND meetings; Represents company at FDA or other agency with regard to methodological issues and support of results)
Master's degree or PhD in statistics or related field in addition to 8 years of pharmaceutical experience. (If PhD in statistics, equivalency is 5 years of pharmaceutical experience.)
Expert knowledge of statistical methodology, including experimental design, linear models, categorical data techniques, nonparametric statistics, and survival analysis
Expert knowledge of developing advanced statistical and probability theory
Expert knowledge of FDA guidelines related to trial design, analysis, and reporting
Solid skills in computer programming (especially SAS)
Excellent writing ability to author reports that will be acceptable to regulatory agencies
Strong analytical, problem-solving, and active learning skills
Strong organizational, documentation, and information gathering skills
Ability to work in multiple therapeutic indications and able to handle multiple projects across these therapeutic areas

Associate Director Biostatistics Resume Examples & Samples

Reviewing whole protocols and interfacing with clinicians and other functions to understand study requirements and design study elements including sample size calculations, analysis methods, study duration, etc. for multiple studies
Developing and/or reviewing statistical documents for multiple clinical trials, including SAPs, TLG shells and specification variable derivation
Developing Study Quality Surveillance Plan and monitoring study conduct to proactively address issues to ensure high quality study data. Conducting sensitivity analysis that addresses missing data issues in longitudinal studies
Developing the Data Monitor Committee charter and liaising with independent statisticians
Providing statistical and validation support for analysis datasets, statistical tables, figures and listings. Performing and validating statistical analysis. Reviewing CSRs and performing data interpretation
Leading preparation of inputs for regulatory documents and ensuring readiness for meetings with health authorities. Leading preparation of responses to health authorities and identification and execution of new analysis required for responses
Directing project team activities to identify biostatistics issues, proposing solutions and providing Biostats support to clinical areas
Developing and maintaining SOPs, SWPs and work guidelines and other related technical documents
Strong expertise in applying statistical methods
Strong programming skills in SAS
Familiarity with statistical software such as EaSt, nQuery, Splus, R and others
Participation in NDA submission activities as a key stat team member
Knowledge of FDA and EMA guidance for drug development
Familiarity with the SDTM, ADaM, eSUB standards and requirements for regulatory submissions and CSR
Ability to handle multiple projects concurrently and within tight timelines
Experience contributing to sensitivity analysis for missing data, longitudinal data analysis and statistical modeling diagnostics
Experience with Bayesian study designs is an added advantage
Excellent interpersonal skills in project management, collaboration and communication to leadership, Study Directors, Data Management, Statistical Programming and other clinical development team members, colleagues, CROs, and external collaborators
Must be flexible to work in a dynamic environment where multi-tasking and changing priorities exist
Must possess strong analytical skills in addition to demonstrated problem solving and risk mitigation skills
Recognized in the profession as a dedicated professional with a strong work ethic
Must be a self-sufficient, highly motivated, highly organized, and proactive individual who is a quick learner
Strong desire to be an independent project leader with initiative, maturity and depth that are required for the complexities associated with drug development

Associate Director, Biostatistics Resume Examples & Samples

Be part of the JDAC team and support the brainstorming and prioritization of the required post-hoc analysis
Provide consultation, input and guidance to cross-functional groups charged with exploratory analyses and lifecycle management projects/studies
Establish and maintain collegial and collaborative relationships with cross-functional group members, Medical Affairs leaders, alliance partners, colleagues in affiliate countries around the world, external medical writers, and external experts and authors
Review draft abstracts and manuscripts according to deadlines, and when appropriate, serve as an author. In some cases, develop abstracts in close collaboration with external medical writers. Serve as group's expert on methods sections
As needed, support statistical analysis needs for dossier and/or response document submissions to HTA/payer bodies and independent therapeutic reviews (i.e. ICER) and analyses required by payers
Assist the Senior Director of Biostatistics when requested in any of his/her job responsibilities
As needed, provide consultant-level support in developing Statistical Analysis Plans (SAPs)/stats sections of Phase 4 protocols (including performing sample size calculations), and supporting feasibility determinations for Phase 4 and HEOR studies, upon request. Consult regarding primary and secondary endpoints as per medical strategy. Upon request, review protocols and SAPs from Investigator-sponsored Studies
As needed, perform all activities listed above, in collaboration with external co-development/commercialization alliance partner companies
Thorough and up-to-date knowledge of statistical methods, especially those related to human clinical studies, including composite endpoints, time-to-event and recurrent event analysis, binary, count and categorical data analysis, longitudinal data analysis (e.g. LME, GEE), missing data methods, nonparametric methods, ANCOVA, responder and treatment failure analyses, data-mining techniques, meta-analysis, etc
Ability to manage effectively one's projects and quickly accommodate to changing priorities, and also to meet tight deadlines while maintaining high quality standards
Ability to explain strategies, approaches, methods, analyses, and findings to non-statistician group members and senior managers. Ability to help others interpret results and place in context.#LI-GZ
Master's degree in Biostatistics or Statistics and 10 years of experience designing and conducting statistical analyses based on experimental data from in vitro, animal and/or human studies, including 8 years of experience designing and conducting statistical analyses from human Phase 3 and/or 4 clinical trial data, both pre-planned and post-hoc, in an industry setting (e.g., pharma, biotech, CRO)
Experience analyzing data from Immunology (RA, Dermatology, Asthma etc.) studies

Associate Director, Biostatistics Resume Examples & Samples

Coach and mentor all staff under him/her; set objectives, solicit feedback from stake holders and conduct performance reviews to foster growth of staff
Ensure all necessary training is provided to his/her staff to support job performance and knowledge; remain cognizant of, and remove, any barriers or obstacles that impede his/her staff from achieving objectives
Ownership of all statistical deliverables
Act as the point of contact for Statistical programming and Biostatistics; responsible for resource allocation within statistical programming
Participate in project team meetings to ensure timelines are met with high quality
Provide programming input and assistance in database design/build
Provide guidance and/or hands-on support in data management activities including but not limited to edit checks, blind data review listings, and CDISC SDTM compliance assurance to ensure a quality locked database
Use efficient programming techniques to produce and/or QC derived datasets, tables, figures, and listings
Create standard SAS MACROS and applications to improve the efficiency of outputs from external vendors to the department
Work on complex problems by developing technical solutions which require the use of ingenuity and creativity
Support creation and validation of eSubmission requirement (i.e., annotated CRF, data export files, define document, etc.)
Act as the lead programmer overseeing technical planning for clinical studies, integrated summary of safety (ISS) and integrated summary of efficacy (ISE)
Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical studies, ad hoc requests, manuscripts, annual reports and other company’s publication needs
Identify and develop standard tools and improvement in statistical programming and Biostatistics
Communicating effectively internally with the project team members and externally with various vendors
Thorough knowledge of functional areas within the clinical development organization including but not limited to clinical operations, data management, statistics, medical writing and regulatory affairs
Deep understanding of the statistics/data management role in the broader clinical development setting
Solid, hands-on knowledge of the use of statistical software (e.g., SAS or SAS Jump including SAS/GRAPH, and SAS/STAT), including report generation is necessary
Prior work experience in the CDISC SDTMs and ADaMs is a must
Prior experience in electronic NDA/BLA submissions via eCTD and responding to FDA/regulatory requests
Strong MS Office skills (Word, Excel, PowerPoint), and skills in generating graphs and figures
Demonstrated ability to work in a team environment
High degree of motivation; results oriented
Minimum of MS in mathematics, statistics or related field
5 to 8 years’ experience from similar work within a pharmaceutical company or CRO is preferable

Associate Director, Biostatistics Resume Examples & Samples

Experience with standard statistical and epidemiological methodologies
Experience in the development of statistical plans
Working knowledge of SAS, STATA, R, and other graphics packages
Experience in analyses of observational studies using large databases including healthcare claims or electronic medical records
Excellent analytical, problem solving, communication and organization skills
Flexibility with changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
Ability to work in a collaborative environment, drive to learn and improve skills
Ability to communicate statistical interpretation to non-scientists
Ability to contribute to the preparation of scientific manuscripts
At least 6 years’ experience in academic or pharmaceutical setting
Ph.D. in statistics or MPH or equivalent degree
Experience supporting Medical Affairs/publication of analysis results (e.g. abstracts, posters, manuscripts) a plus
Experience leading analyses of large external datasets
Experience with data extraction, cleaning, and analysis
Strong record of scientific publications
Overnight travel up to 10%

Associate Director, Biostatistics Resume Examples & Samples

Independently lead one or more projects ensuring the proper design, analysis, and presentation of clinical studies while adhering to timelines and departmental quality-control standards
Incumbent interacts with domestic and foreign regulatory agencies for Allergan R&D projects
Monitors budgetary and resource needs, and evaluates, hires, and manages CROs and/or contract biostatisticians
Assist statistical science process development as needed to improve the efficiency and standardization
Represent Statistical Science and Programming on cross-functional project teams

Associate Director Biostatistics Resume Examples & Samples

10 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting
Experience providing statistical leadership at compound/indication level
Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy
Solid experience in applications of advanced statistical methodologies
Leading roles in regulatory submissions
Experience in interactions with major regulatory authorities preferred
Experience managing CRO preferred
Track record of innovation desired

Associate Director Biostatistics Resume Examples & Samples

Study Level
Effective utilization of innovative statistics and quantitative analytics to influence assigned program team decisions and support department to deliver objectives
Proven knowledge and expertise in statistics and its application to clinical trials. Demonstrated excellence in use of statistical software packages (e.g. SAS, R). Strong knowledge of drug development and Health Authority guidelines. Experience independently leading a multidisciplinary team to achieve team objectives. Expert skills to facilitate and maximize the contribution of quantitative team. Hands-on experience in leading the interface to regulatory agencies/leading the early clinical development campaign
Strong understanding of Franchise/Therapeutic Area and or regulatory activities. Expert scientific leadership skills demonstrated in facilitating and optimizing the (pre/early/full-) clinical development strategy. Strong track record for global scientific leadership in the development and evaluation of modern program/trial design methodologies
May have proven people leadership ability. Demonstrated strong skills in building partnerships and collaborations. Demonstrated skills in coaching and mentoring associates
Good business ethics

Associate Director, Biostatistics Resume Examples & Samples

Participates in project teams for clinical development programs and/or lifecycle management of marketed Oncology products
Provides strategic statistical input to the project teams and is a major contributor to the clinical development plan (CDP). Ensures CDP with statistical integrity and optimal study designs, and ensures that Data Science needs are reflected within the development plan and strategy across regions. Provides statistical advice to clinical teams including design of studies and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may impact the statistical integrity of the development program or for which statistical tools may add value
Provides best in class data science support to Astellas Oncology drug development programs and leads the Data Science extended (project) team and deliverables teams. Ensures quality and consistency of key data science deliverables across studies. Ensures creation of, maintenance and adherence to indication specific standards with respect to key variables, definitions, statistical methods, data structures and presentation of results
Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs. Represents the company on statistical matters at meetings with regulatory authorities, key opinion leaders and similar experts / bodies
Reviews key project and study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, clinical development plans (CDPs), protocols, analysis plans, study reports, submission documents and correspondence with health authorities
Major contributor to cross-departmental/departmental/sectional improvement initiatives, for example: write SOPs; select, validate and implement statistical software; generate standard output or analysis methods
Member or leader of external industry or professional organizations. Develops and maintain relations with leading academic institutions
Perform vendor qualification / audits in collaboration with functional management
Investigates new statistical methodology and feeds back to department and project teams
Participates in due diligence activities, reviews data and advises company
LI-ML
M.S. or Ph.D. in statistics or equivalent
Minimum of 8 years experience in applying statistical methods in biomedical research, extensive pharmaceutical or CRO experience required
Experience in working on clinical project teams. Good understanding of entire drug development process - ability to see the "big picture"
Experience as the independent lead statistician in a regulatory submission preferred
Experience with cross functional process improvement or innovation initiatives
Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical data
Knowledge and skills in SAS required and knowledge of other statistical software preferred
In-depth familiarity with processes and procedures in data management and SAS programming
Experience working in an international environment and demonstrated ability to manage and influence across different locations, time zones and cultures; builds global relationships
Proven excellent organizational, project and time management skills
Leadership skills and ability to delegate appropriately and provide direction to more junior Biostatisticians
Very good oral, written, and presentation communication skills. Able to clearly communicate statistical issues and methods to both statisticians and non-statisticians
Very good problem solving skills
Accurate with a keen eye for detail. Dedication to quality and reliability in all work tasks

Associate Director, Biostatistics Resume Examples & Samples

Lead multi-study proposals and projects (up to $1M, 2 to 3 business lanes, large project teams)
Participate independently in sales calls, capabilities pitches, and bid defenses
Lead proposal and budget writing
Participate in the creation and execution of a yearly strategic plan
Interview and evaluate candidates
Effectively mentor, with the possibility of supervising more junior teammates
Effectively work with internationally remote and culturally diverse teammates
Attend sales calls and bid defenses
Lead or coordinate proposal and budget writing
Lead report, manuscript and abstract creation
Participate in weekly business lane meetings
Manage his/her capacity and utilization across multiple projects
Work effectively with human resources
Interact effectively with sales and marketing
Interact effectively with teammates in other business lanes
Functioned as a member of a product or project team
Coauthor on ≥ 15 abstracts and ≥7 peer-reviewed articles
Supported interaction with US and/ or ex-US regulators and/or payers
Participated in design and/or execution of Phase 2-4 registrational trials
At least 1 year of experience in consulting

Associate Director, Biostatistics Resume Examples & Samples

Provide operational and strategic direction to project statisticians
Manage multiple projects including timelines, resource planning and allocation
Apply statistical techniques to facilitate better decision making and improve business operation
Participate in strategic planning at an executive level
Participate in planning and carrying out organization development and professional growth of staff statisticians
Collaborate with other statisticians in improving and sharing statistical approaches
Collaborate with colleagues from other divisions or departments to achieve corporate goals
Participate in establishing medical departmental and nonclinical SOPs and guidelines
Develop statistical courses and provide training to scientists
Supervise direct reports
Preside over external student internship programs (if funded)
Demonstrated ability in supervising and mentoring people
Demonstrated competency in managing multiple projects and processes
Comprehensive knowledge of applied statistical principles and modeling in the design and analysis of non-clinical studies and proficiency in statistical software such as SAS and R
Apply advanced statistical principles, theories, and concepts
Contribute to the development of novel statistical methods to solve R&D problems
Excellent interpersonal skills and effective oral and written communication skills
Excellent organizational skills and successful management experience
Experience in departmental SOP and process development improvements
Comprehensive knowledge of regulatory guidelines
Experience in regulatory interactions and submissions