Manager, Biostatistics Resume Samples

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D Herzog

Destiny

Herzog

6597 Celine Vista

Philadelphia

+1 (555) 584 0243

6597 Celine Vista

Philadelphia

Phone

p +1 (555) 584 0243

Experience Experience

San Francisco, CA

Manager, Biostatistics

San Francisco, CA

Lynch-Fritsch

San Francisco, CA

Manager, Biostatistics

Participate and lead in process improvement, training, standards development and enhancing statistical technical expertise
Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation
Work closely with data management, clinical operations, statistical programming, and other biostatisticians to develop and possibly validate study-specific data capture systems
Collaborate with members of project teams to establish project timelines and to develop and implement protocols
Provide timely and scientifically sound statistical expertise to clinical development projects
No current management responsibilities of direct reports; may have people management responsibilities in the future
Work with the clinical teams in designing clinical studies, writing the statistical analysis plans, conducting the statistical analyses, and providing statistical support for the clinical study reports, scientific presentations and manuscripts

New York, NY

Senior Manager Biostatistics

New York, NY

Huels, Daugherty and McLaughlin

New York, NY

Senior Manager Biostatistics

Supervises staff, including setting performance goals and providing feedback as determined by the manager
May manage other individuals in functional area (e.g. statisticians, SAS programmers) and mentor junior statisticians as determined by line manager
Provides statistical advice to project teams including design of studies and analyses and is a contributor to the Clinical Development Plan (CDP)
In consultation with functional management, selects vendors
Proven success in the line management of supervisory staff
Provides CRO with study details and timelines
Reviews and provides input into critical documents, such as CRFs and Data Validation Plans

present

Phoenix, AZ

Senior Manager, Biostatistics

Phoenix, AZ

Keeling-Ruecker

present

Phoenix, AZ

Senior Manager, Biostatistics

present

Working knowledge of SAS and / or R
Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
Establishes and maintains effective working relationships with vendors and project teams
Provides statistical expertise and input to drug development programs and safety surveillance including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value
Provides statistical expertise and input to drug development programs, including the design of translational research / biomarker analysis plans, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value
Proven performance in leading complex projects
Contributing to the development of submissions to worldwide regulatory agencies (e.g. NDA, MAA)

Education Education

Bachelor’s Degree in Biostatistics

Georgia Southern University

Bachelor’s Degree in Biostatistics

Skills Skills

Proficient in using SAS; knowledge of other statistical applications and programming languages
Strong knowledge of SAS and clinical biostatistics
Demonstrated knowledge of the drug development process and FDA regulations
Advanced knowledge of clinical trial design and analysis
Demonstrated ability to manage change and uncertainty to optimize positive outcomes
Review position papers based on current good statistical practice
Excellent in both oral and written communications
Excellent oral and written communications skills
Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting
Excellent verbal and written communication skills

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Manager, Biostatistics Resume Examples & Samples

Work with the clinical teams in designing clinical studies, writing the statistical analysis plans, conducting the statistical analyses, and providing statistical support for the clinical study reports, scientific presentations and manuscripts
Participate and lead in process improvement, training, standards development and enhancing statistical technical expertise
Take the initiative to liaise with other statisticians within the organization, and build working relationships with cross-functional team members
A PhD in Statistics or related field with 2 years of experience in the pharmaceutical industry is required
Excellent analytical skills and knowledge of statistical methodology including experience with modeling and simulations are required
Proficiency with statistical software such as SAS, R or SPlus is required
Excellent verbal and written communication skills, including presentation skills, are required

Manager, Biostatistics Resume Examples & Samples

Line management of staff including: performance management, progressive discipline, and training need identification. Recommends courses of action on salary administration, transfers, new hires, terminations, and professional development. Regularly communicates with staff on working practices, policies, and work instructions
Ensures that the local Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements, and identifies the need for contract modifications due to out of scope activities
Assigns Biostatisticians to projects in a manner which aims to keep associates at their utilization goal and which matches associates to projects appropriate to their skills, training, and experience, while also providing opportunities to work with varied projects, sponsors, and teams
Prioritizes activities across biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals which promotes teamwork and quickly restores department effectivenes
Responsible for staff development to facilitate succession planning and maintaining a biostatistics staff with diverse skills, abilities, and competencies meeting the business needs of Biostatistics department
Sets challenging, achievable goals for associates which contribute to department objectives and supports efforts to achieve those goals. Provides motivating, timely performance feedback to associates on a routine basis as well as for formal performance appraisals
Assists Biostatisticians in solving technical problems with effective, cost-efficient resolutions
Supports business development activities by contributing to proposals, request for information, budgets, and attending sponsor bid defense meetings
Maintains a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and biostatistics in order to effectively serve as a statistical department resource, mentors Biostatisticians on job skills, oversees or develops training plans or materials for Biostatistics associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing personnel
Conducts senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents

Manager Biostatistics Resume Examples & Samples

PhD in statistics or biostatistics with 5 years relevant experience in the pharmaceutical industry or M.S. in statistics or biostatistics with 7 years relevant experience in the pharmaceutical industry
Working knowledge of drug development and statistical methodologies and statistical software such as SAS, nQuery, EAST, etc
Working knowledge of clinical trial methodologies
Excellent programming skills in SAS and/or R
Working knowledge of pharmacology, clinical research, and medical terminology for study design and results interpretation
Able to identify issues and causes, use logic and reason to evaluate information in developing remediation plans
Able to start developing and execute strategic plans
Able to prioritize multiple tasks and manage vendors in completing the deliverables with high quality according to timelines
Compliant with internal and external compliance practice to ensure integrity of work

Manager, Biostatistics Resume Examples & Samples

8 years of industry experience in the statistical analysis of biomedical data using SAS® software and a BS degree in Biostatistics or equivalent
4+ years of industry experience in the statistical analysis of biomedical data using SAS® software and an MS degree in Biostatistics or equivalent
2+ years with PhD degree in Biostatistics or equivalent

Senior Manager, Biostatistics Resume Examples & Samples

Provides statistical expertise and input to drug development programs and safety surveillance including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value
Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Authors technical reports and publications, ensures the timely delivery of top line study results
Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
Ability and experience to work with safety to develop appropriate tools and analysis strategies for safety surveillance
Monitors project progress and ensures proper resource allocation; performs vendor oversight for assigned programs and provides quality review of vendor deliverables
Establishes and maintains effective working relationships with vendors and project teams
Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology; maintains currency with developments in these fields

Manager, Biostatistics Resume Examples & Samples

Provide timely and scientifically sound statistical expertise to clinical development projects
Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies
Collaborate with members of project teams to establish project timelines and to develop and implement protocols
Work closely with data management, clinical operations, clinical data analysis, and other biostatisticians to develop and validate study-specific data capture systems
Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation
Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables. Participate in CRO selection process
Attend regulatory meetings to support and defend clinical programs
Collaborate with clinical scientists, thought leaders, and medical writers, both internally and externally, in the publication of study data
Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc
Advanced knowledge of clinical trial design and analysis
Proficient in US drug development regulatory requirements as they relate to statistics
Experience in contributing to NDAs or BLAs
Familiarity with pharamcokinetic/pharmacodynamic data, a plus
Proficient in using SAS; knowledge of other statistical applications and programming languages a plus
Experience using CDISC SDTM and ADaM models and standards
Experience supporting publication of analysis results (e.g. abstracts, posters, manuscripts) a plus
Excellent in both oral and written communications
MS or PhD in statistics, mathematics, or related field, with 8+ years (MS) or 4+ years (PhD) of industry experience in clinical trials

Senior Manager, Biostatistics Resume Examples & Samples

MS or PhD in Statistics or Biostatistics
>5 years clinical trial experience in either a biotechnology or pharmaceutical company
Hands-on Phase IIb/III clinical trial experience and proficient in SAS programming
Excellent oral and written communication skills, and proficient in presenting power point presentations
Although not required, previous support of regulatory submissions in the US, Europe, or Japan
Although not required, previous clinical trial experience in the therapeutic areas of dermatology and/or oncology

Manager, Biostatistics Resume Examples & Samples

Provide leadership to the biometrics team (data management, programming, statistics) on a given clinical program, group of programs, or key study(ies); review work of statisticians supporting this work
Provide update on program progress with focus on biometrics to management
Collaborate with Medical Directors and other study personnel on the creation of clinical development plans and clinical trial designs
Perform or oversee performance of power/sample size calculations to determine appropriate trial size; run simulations to assess operating characteristics of designs
Provide statistically sound experimental design and data analysis input to meet project objectives and regulatory (e.g. FDA) requirements
Design and write statistical sections for clinical trial protocols or oversee this work
Generate study randomizations and provide input on maintaining study blinding
Design and write statistical analysis plans for clinical trials or oversee this work
Write statistical sections of regulatory submissions or oversee this work
Design and conduct statistical analysis of clinical data or oversee this work
Work with medical monitors to develop ad hoc analysis plans and perform analyses or ensure analyses are performed appropriately by programming staff
Represent Seattle Genetics statistical position to regulatory agencies
Key contributor in project planning (timelines, etc) with clinical, regulatory and data management
Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings
Become knowledgeable in disease areas under study (e.g. available treatments, course of disease, endpoints, analyses used for previous submissions)
Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Knowledge of FDA regulations, ICH GCP guidelines, the drug development process
Manager: MS or Ph.D in Statistics/Biostatistics or related field - with 8 or more years of relevant experience for MS and 6 or more years of relevant experience for Ph.D
Sr Manager: MS or Ph.D in Statistics/Biostatistics or related field with 10 with 8 or more years of relevant experience for MS and 8 or more years of relevant experience for Ph.D
Previous experience providing leadership to biometrics staff within a clinical team
Knowledge and experience to exercise independent judgment and provide indirect oversight to programmers, data managers, and more junior statisticians
Sound understanding of ICH guidelines and FDA requirements
Proficiency with SAS® procedures and programming language

Manager Biostatistics Resume Examples & Samples

Manage a team of Biostatistics staff. Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments
Supervision and management of staff; with special attention to training and skill set development
Participate in the formal review processes e.g. performance and salary reviews to corporate standards and timescales
Plan and manage resources across the projects / staff, including active involvement in interviewing, retention, and absence issues
Ensure that staff utilization and productivity expectations are met
Report on project related issues to senior management as appropriate
Provide training and guidance to lower level and new staff
Performs senior technical review and quality assurance of biostatistics’ work products (e.g. Protocols, SAPs, TLFs etc.)
Understand the Scope of Work, budget and quote assumptions, estimate the work completed, and manage scope for studies
Review RFPs and prepare proposal text and may attend bid defense meetings
Cooperate with counterparts in other locations as required
Where required, take on role of Biostatistics Lead, taking responsibility of Biostatistics services
Excellent SAS programming skills
Knowledge of Windows application
Strong oral and written communication skills (including the ability to communicate statistical concepts and information to non-statisticians)
Knowledge of SDTM and ADaM
Knowledge of pharmacokinetic data
Knowledge of electronic submissions
Effectively handle multiple tasks and projects
Effectively handle team of biostatistician/biostatistical programmers
A good understanding of resourcing and budgeting; business awareness
Behavioral Competency
Professional attitude, Self-motivated, Logical Thinking, Attention to detail
Ability to establish and maintain effective working relationships with co-workers, managers and Customers
Ability to manage and motivate direct reports
Ability to effectively delegate
Master's degree in Statistical science preferred or equivalent combination of education and training
PhD in Statistics or related discipline is preferred
Base SAS, SAS/MACROS, SAS/GRAPH, SAS/STAT and CDISC knowledge preferred
Experience in Early Phase studies
Language Skills
Fluent in English (speak, read, write)
Minimum Work Experience
≥ 10 years of experience
Management Experience: 1 to 2 years’ experience

Manager, Biostatistics Resume Examples & Samples

Master's degree in statistics, biostatistics, or related field with appropriate statistical coursework and 5 years of experience
Or PhD in statistics, biostatistics, or related field with appropriate statistical coursework and 3 years of experience
Evidence of strong staff management skills, as shown through the successful management of multiple projects and staff members, and proven ability to mentor and motivate staff
Positive attitude and the ability to proactively direct and promote teamwork in a multi-disciplinary team setting
Strong knowledge of SAS and clinical biostatistics

Senior Manager Biostatistics Resume Examples & Samples

Provides technical expertise and guidance in the development of protocols, analysis plans, programming specifications, interpretation, and writing of results
Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management
Provides budgetary reconciliation against actual expenditure. Identifies and quantifies the budget and expense differences
Ensures the effective resource and utilization management of staff
Recruits, trains and develops employees
Prepares proposals and participates in business development presentations
Participates in strategic client franchise leadership
2+ years of management responsibility
Proven success in the line management of supervisory staff
Demonstrated ability to manage change and uncertainty to optimize positive outcomes

Senior Manager, Biostatistics Resume Examples & Samples

Serves as lead statistician on large scale/complex projects
Oversees the project work of directly reporting statisticians
Acts as a senior statistical reviewer commensurate with expertise and ability
Provides first level of PPD management communication with clients
Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope
Ensure SOP and FDA guideline adherence
Leads departmental management in process-improvement strategies
Engages in raining and professional development
Provides line management of staff
2+ years clinical trials experience
Strong knowledge of SAS® and clinical biostatistics

Manager Biostatistics Resume Examples & Samples

All experience must include a minimum of 2 years of clinical trials experience and a minimum of 1 year supervisory/management experience
Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills and abilities
Demonstrated initiative and motivation
Proven performance in leading complex projects
Demonstrated knowledge of the drug development process and FDA regulations

Manager, Biostatistics Programming Resume Examples & Samples

Work with minimal supervision to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project
Ensures standardization and data pooling for regulatory submissions. Ensures appropriate resource allocation
Implement standard applications and tools within the WW Biostatistics organization
Function as a lead programmer in the development and QC of tables, listings, graphs in support of analysis requirements utilizing sanofi-aventis tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM). Provide technical guidance to the programming team
Creation of formatted output for use in clinical study reports, publications, safety monitoring board reviews, annual updates, presentations, and response to regulatory authority queries
Facilitate the development of standard tools and database structures for implementation within the WW Biostatistics organization
Manage the effort, including esubmssion deliverables, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables
Ensures timelines are met, deliverables conform to company and industry standards
Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials
Work with team to meet required milestones to ensure high quality contribution to the decision-making processes
Work with management to determine resource requirements. Provide feedback to management regarding team members' contributions to the work effort for evaluating individual's performance
Ensure key contributors are being identified and recognized for their effort and provide an environment that fosters recognition and rewards
Actively participate or lead in department working groups
Participate in user requirements, process development and standardization. Ensure operational efficiency
Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred
Master degree and 5+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
Bachelor degree and 7+ years of programming experience peferably in processing clinical trial data in the pharmaceutical industry
Advanced SAS programming skills in a clinical data environment with expertise in at least one therapeutic area
Strong understanding of relational databases and experience working with complex data systems. Knowledge of CDISC data structure requirements
Experience in development and implementation of standardization methodology within at least one therapeutic area
Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation. Ability to solve complex problems independently. Excellent verbal and written communication skills in a global environment
Experience in pharmaceutical clinical development in at least one therapeutic area (i.e. understanding of statistical concepts, techniques and clinical trial principles within a therapeutic area). Ability to lead programming deliverables based on regulatory submission requirements
Experience in project management with minimum supervision. Ability to effectively organize and manage multiple assignments with challenging timelines across multiple personnel
Experience in project start-up through submission. Experience in collaboration with external partners and/or vendors
Experience in the development, evaluation and support of junior staff and contractors
Ability to estimate resource requirement

Senior Manager, Biostatistics Resume Examples & Samples

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

Manager Biostatistics Resume Examples & Samples

During your degree in Applied Statistics / Data Sciences or Bioinformatics you have gained experience in the analysis and modelling of complex biological data
In addition, you have a solid knowledge of machine learning and the application of standard statistical techniques including linear modelling
You are fluent in programming in R and with a fair to excellent knowledge and understanding of programming R-Shiny apps. Your knowledge in Python or JavaScript is complementing your programming skills
Excellent oral and written communication skills in English and preferably German are your means to convey your expertise to our customers
In addition to your professional skills, your distinct entrepreneurial and team spirit is persuading

Manager, Biostatistics Resume Examples & Samples

This document has been electronically approved. Refer to the Approval Certificate at the end of the document for details
Performs other work-related duties as assigned
Minimal travel may be required (up to 25%)
MS or PhD in Biostatistics or related field. Extensive experience in clinical trials or equivalent combination of education and experience
Experience with regulatory submissions preferred
Extensive knowledge of the drug development process and FDA and ICH guidelines and demonstrated leadership ability
Effective written and verbal communication skills. Ability to apply knowledge of statistical design, analysis, and programming techniques used in clinical trials. Ability to read, write, speak, and understand English

Manager Biostatistics Resume Examples & Samples

During your PhD in natural sciences with a focus on Biostatistics / Bioinformatics or your degree in Applied Statistics / Data Sciences, you have gained experience in modelling biological or agricultural data
In addition, you have a solid knowledge of experimental design and the application of linear models and/or the use of machine learning in these fields
You are fluent in programming in R and have an understanding of programming R-Shiny apps. Your knowledge in Python or JavaScript is complementing your programming skills

Senior Manager, Biostatistics Programming Resume Examples & Samples

Provide programming leadership for clinical studies, including but not limited to the resource estimate, development and validation of SDTM, AdaM and TFLs. Assumes responsibility of the overall timelines of planned and unplanned analyses of the studies
Provides programming expertise and input to planned and unplanned analyses, including the structure of standard and derived datasets, and the planned documentation of programming activities and TFLs
Recognizes and addresses issues which may affect the integrity of the data structure and reproducibility of analyses
Deep understanding of the theories and methodologies of conversion, tabulation, analysis, reporting, and integration of clinical data
Ability to apply knowledge of SAS ® programming application and other software languages and tools along with knowledge of industry-accepted standards, including CDISC SDTM and ADaM
Develop and manage programming services; providing programming resources and project management of clinical programming activities and deliverables
Provides programming input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
Provides strategic guidance and in-depth critical review for the development of Case Report Forms (CRFs) and database designs; ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Maintains programming documentation and ensures archival and reproducibility of all analyses
Develop and implement standards related to derived data sets and submission data sets
Responsible for monitoring regulatory guidance and industry best practices
Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks

Manager, Biostatistics Resume Examples & Samples

Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of Jazz Pharmaceuticals products
Participate in Publication Planning Meetings as a Biostatistics representative; contribute to publication planning including timelines, statistical and analytical requirements for publications, projects, and publications plans
Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate
Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries
Review publications, marketing materials, and education and training materials that contain clinical data and product claims
Stay informed with data being generated in current clinical development programs
Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results as necessary
Provide guidelines and standards to CROs to ensure quality of deliverables
No current management responsibilities of direct reports; may have people management responsibilities in the future

Senior Manager, Biostatistics Resume Examples & Samples

Produce or oversee the production of protocol development (study design, endpoint selection, statistical methods section) and detailed statistical analysis plans that lead to comprehensive statistical/clinical study reports suitable for regulatory submissions
Represent the Biostatistics function on Clinical Project Teams for the development of new pharmaceutical products, advising cross-functional partners (e.g., Project Medical Leader, Clinical Pharmacology, Clinical Operations, and Regulatory Affairs) on statistical issues
Research statistical methods to assure state-of-the-art Statistical Analysis Plans that meet regulatory requirements
Perform statistical analyses of clinical data as necessary for management decisions, regulatory requests for information, and commercial support

Senior Manager, Biostatistics Resume Examples & Samples

Reporting to the Vice President, Clinical Operations & Translational Sciences; The Senior Trial Manager of Biostatistics will be
Contributing to the development of study protocols, in particular, the statistically-related sections (e.g. sample size calculations, statistical methodology, and statistical analyses)
Identifying the most appropriate analytical models/methods for clinical studies, and conducting research on statistical methodology, as needed, to accomplish this
Developing detailed statistical analysis plans; independently determine appropriate statistical methodology for data analysis
Participating in database design meetings to ensure that data are free of bias, contain maximum information (minimum variance), and satisfy analytical requirements
Evaluating the appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology
Analyzing data and interpret results from studies to meet objectives of the study protocol; independently apply and implement basic and complex techniques to these analyses
Preparing oral and written reports to effectively communicate results of clinical trials to the project team, senior management, regulatory agencies and/or individual investigators
Communicating effectively with regulatory agencies, in meetings and in written material (e.g. briefing documents) the statistical methodologies, analyses, and results of clinical studies
Contributing to the development of submissions to worldwide regulatory agencies (e.g. NDA, MAA)
Contributing to responses to queries relating to study design, data analysis, and output interpretation posed by clinical monitors, regulatory agencies, and/or investigators
Solid, hands-on knowledge of the use of statistical software (e.g., SAS or SAS Jump), including report generation is necessary
Prior work experience in the rare disease space is strongly desired; primary focus is on clinical trials with small sample sizes
Strong MS Office skills (Word, Excel, PowerPoint), and skills in generating graphs and figures
High degree of motivation; results oriented

Senior Manager Biostatistics Resume Examples & Samples

Contributes to the efficient planning, execution and reporting of clinical studies
Reviews protocols to ensure statistical integrity and consistency
Reviews and provides input into critical documents, such as CRFs and Data Validation Plans
Develops statistical analysis plans (SAPs) and tables, listings and figure (TLF) specifications
Performs statistical analyses for clinical studies in accordance with the protocol, statistical analysis plan, good statistical practice and available regulatory guidelines
Implements study analyses, including providing programmers with efficacy analysis algorithms, programming or QCing inferential statistical analyses and reviewing outputs and analysis results
Interacts with ASA programmers and CROs in the coordination of data summaries and analysis activities
Contributes to key study reports (e.g. clinical study reports) and other documents included in regulatory submission and provides statistical interpretation of the results
Provides statistical advice to project teams including design of studies and analyses and is a contributor to the Clinical Development Plan (CDP)
Seeks peer/manager review within statistics to ensure CDP with statistical integrity and optimal study designs, and to ensure that the Biostatistics needs are reflected within the CDP
Recognizes and addresses issues which may impact the statistical integrity of the development program
Influences project team members from all disciplines on statistical design and methodology topics
Reviews and provides input to in vivo pharmacology studies
Accumulates and maintains programming skills and relevant knowledge of statistical methods for clinical trials and regulatory guidelines in the pharmaceutical industry and the therapeutic area(s) of interest
Assesses the resources needed for Agensys Biostatistics and is responsible for hiring new staff and contractors
Trains and coordinates statisticians within a project or set of studies; may mentor more junior statisticians
Supervises staff, including setting performance goals and providing feedback as determined by the manager
Represents Agensys (Astellas) in professional organizations and industry groups
Represents Agensys (Astellas) on statistical issues in interactions with health authorities
Participates in writing the protocols of clinical studies to ensure that that the data collected may be used to reach valid conclusions about the hypotheses under investigation; statistically analyzes experimental data, documents the methods used, and presents the results in a format consistent with health authority guidelines so that the results of clinical, pharmacokinetic, and preclinical studies may be included in approvable new drug applications
Approval and successful commercialization of a new drug require the presentation of statistical evidence demonstrating the effectiveness, safety and competitive advantages
Conducting appropriate clinical studies and research studies expeditiously according to good statistical practices can result in more rapid accumulations of the needed information and a clearer understanding of the results
The solid contribution of this position is critical to the success of a drug development program to ensure its integrity and maximize the commercial potential
A Sr. Biostatistics Manager may be assigned to approximately 1-3 compounds simultaneously in 1-2 indications and may work closely on 4-6 studies at a time. He/she undertakes work independently, in an established area, and under guidance for complex novel projects
Closely collaborates with project and study team members (e.g. programmers, data managers, clinical study managers, study medics, regulatory affairs, clinical pharmacology, project management, medical lead)
Instructs SAS programmers on the design of tables, listings and graphs needed for a report and reviews them for content and format
May manage other individuals in functional area (e.g. statisticians, SAS programmers) and mentor junior statisticians as determined by line manager
M.S. or Ph.D. in Statistics or equivalent degree
Minimum 5 years of experience in applying statistical methods in biomedical research
Advanced knowledge of statistical methods for design of statistical of clinical studies and analysis of clinical data
Very good oral and written communication skills
Ability to clearly communicate statistical issues and methods to both statisticians and non-statisticians
Ability to interact across different cultures and build global relationships
Accurate and keen eye for detail and dedicated to quality and reliability in all work tasks
Very good interpersonal skills to effectively work in cross functional project teams
Good knowledge and skills in SAS required and knowledge of other statistical software as well is preferred
In depth familiarity with processes and procedures in data management and SAS programming
Good organizational, project and time management skills
LI-TW

Manager Biostatistics Resume Examples & Samples

In collaboration with clinical, scientific and medical counterparts, ensure that the statistical approach and analysis strategies are robust and aligned with the regulatory and business objectives
Contribute to the clinical development and study execution strategy, including the product assessment plan to define the clinical assessment, safety surveillance, and post-market assessment programs
Work across multiple studies across product platforms, with the responsibility for fully integrating the statistical strategy and interpretation over the entire product lifecycle
Manage and oversee the CROs selected to operationalize the studies with focus on the governance to ensure the quality and timeliness of the deliverables across the entire program
Interact with senior management, scientific advisors, and external key opinion leaders for quantitative aspects of the program and identify opportunity for contributing to publications and white papers
Manage a team of statisticians, data analysts and statistical programmers internally

Manager, Biostatistics Resume Examples & Samples

Provide broad statistical support, including trial design, protocol and CRF development on specific studies
Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents
Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols
Review publications and clinical study reports
Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans
Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review
Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis
Understand, apply and provide training in extremely advanced and sometimes novel statistical methods
Contribute to the development and delivery of internal and external statistical training seminars and courses
Review position papers based on current good statistical practice
Interact with clients and regulatory authorities
Support of Business Development, e.g. by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings
Travel to, attend and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results)
Additional responsibilities as defined by supervisor/manager
Good analytical skills and project management skills
Professional attitude and Attention to detail
Thorough understanding of statistical issues in clinical trials
Ability to clearly describe advanced statistical techniques and interpret results
Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
Prior experience with SAS programming require
Ability to work independently and Good mentoring/leadership skills
Good business awareness/ business development
Experience with CDISC is a plus

Senior Manager, Biostatistics Resume Examples & Samples

Participates in defining how the project will be performed and the deliverables that will be presented
Prepare Proposals: Reviews and revises draft proposals that respond to client requirements following standard formats used for previous engagements
Supervise Data Collection and Analysis: Identifies sources and obtains information from knowledgeable individuals, reference texts, on-line databases, and other research sources. Evaluates data using quantitative methods as necessary to allow appropriate inferences and conclusions to be drawn
Review Summaries: Reviews and advises on analyses of key points, patterns, and trends found in data
Develop Findings and Recommendations: Assists in using information and data to prepare specific findings and recommendations, which are appropriate to client requirements
Interface with Internal Project Management and Client: May meet with client to review work plan, schedule meetings, describe data sources, explain patterns observed in data, and indicate how findings and recommendations were developed
Prepare and Present Deliverables: Prepares written protocols, analysis plans, memos, correspondence, and reports; conducts in-person presentations for clients
Generate Repeat Business: Establishes business relationship with clients that results in repeat business for the Company
Train and Mentor Staff: Act as a mentor to less experienced consulting staff, orienting them on company policies and career development objectives
Supports Other Areas: Supports other functions of the company as needed
Experienced candidates with a doctoral degree should have 7+ years of experience in consulting on Phase III clinical trials and/or late-phase observational studies/registries
Strong knowledge of standard and advanced statistical techniques, especially in relation to observational studies
Good understanding of the clinical trial process and late phase/observational studies (e.g., Phase IV, registries, retrospective chart review, time and motion studies)
Good understanding of basic study designs (e.g., cross sectional, parallel group)
Able to lead protocol and analysis plan development
Able to oversee junior biostatisticians and SAS programmers
Able to write and review SAS code for complex models
Good understanding of CDISC standards (SDTM, ADaM)
Able to write reports and publications
Communicate effectively with global internal and external team members
Strong project and budget management experience
Working knowledge of Microsoft Word, PowerPoint and Excel

Manager, Biostatistics Resume Examples & Samples

Work closely with data management, clinical operations, statistical programming, and other biostatisticians to develop and possibly validate study-specific data capture systems
Attend regulatory meetings to support and defend clinical programs as necessary
Experience with CDISC SDTM and ADaM models and standards
MS/MPH or PhD in statistics, mathematics, or other applicable field, with 8+ years (MS) or 4+ years (PhD) of pharmaceutical/biotech industry, clinical research or other applicable experience

Manager Biostatistics Resume Examples & Samples

Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company
Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses
May participate as a member of a Data and Safety Monitoring Committee
May participate as high level lead biostatistician on major project(s) including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, ISSs, ISEs and/or NDA sections, as required
Oversee collection and reporting of Biostatistics metrics, implementation of revised work practices, new guidelines, and new software tools as they become available
Provide training, guidance and mentorship to lower level and new staff
Coordinate and participate in process improvements and interoffice/interdepartmental task forces to achieve the partnership goals
Make recommendations about resource allocation so as to achieve target utilization rates and project realization rates
Assist in the following: (i) sales meetings as required; (ii) overseeing proposal and budgeting preparation; (iii) ensuring that all proposals bid by the department have an adequate budget, and sufficiently detailed set of budget assumptions
Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials
In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
Strong working knowledge of SAS
Working knowledge of relevant Data Standards (such as CDISC/ADaM)
PhD in biostatistics or related field and 5 years relevant experience including 2 years experience managing staff; Master's degree in biostatistics or related field and 7 years relevant experience including 2 years experience managing staff; Bachelor's degree in biostatistics or related field and 10 years relevant experience including 2 years experience managing staff