Associate Director, Biostatistics Job Description
Associate director, biostatistics
provides strategic and statistical leadership on study designs, statistical analysis plans, data analyses and statistical reports consistent with regulatory requirements for companion diagnostic product development and validation.
Associate Director, Biostatistics Duties & Responsibilities
To write an effective associate director, biostatistics job description, begin by listing detailed duties, responsibilities and expectations. We have included associate director, biostatistics job description templates that you can modify and use.
Sample responsibilities for this position include:
Provide statistical leadership and support for the clinical development of anticoagulants in the cardiovascular area with a focus on the prevention and treatment of venous thromboembolism, stroke and acute coronary syndrome
Work with the clinical teams in designing clinical studies and case report forms, writing the statistical analysis plans, exploring clinical database, conducting the statistical analyses, and providing statistical input for the clinical study reports, scientific presentations and manuscripts
Lead the strategies and discussions with Health Authorities and serve as a statistical responder in FDA advisory committee meetings
Take a leadership role in process improvement, training, standards development and enhancing statistical technical expertise
Take the initiatives to liaise with other statisticians within the organization, and build working relationships with cross-functional team members
Take the ownership to develop themselves and team members
Serve as the primary contact to outside investigators in the preparation of scientific presentation and manuscripts
Take a leadership role in process improvement, training, standards development or enhancing statistical technical expertise
Provide statistical input for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support
Contribute/lead clinical study design, analysis planning and for the development of statistical analysis plan (SAP) and data presentation plan (DPS) for MA studies
Associate Director, Biostatistics Qualifications
Qualifications for a job description may include education, certification, and experience.
Education for Associate Director, Biostatistics
Typically a job would require a certain level of education.
Employers hiring for the associate director, biostatistics job most commonly would prefer for their future employee to have a relevant degree such as Master's and Associate Degree in Biostatistics, Statistics, Mathematics, Technical, Education, Applied Statistics, Public Health, Biotechnology, Human Studies, Conducting
Skills for Associate Director, Biostatistics
Desired skills for associate director, biostatistics include:
CDISC requirements for SDTM and ADaM
Concise
High-quality results
Medical/biological terminology and clinical trial designs in relevant therapeutic areas
Statistical methodology that is appropriately applied in trial design and data analysis for clear
Data management
SAS procedures and other statistical software
Regulatory laws / procedures outside of US and Europe
Drug development regulations pertinent to statistical analysis
Statistical methodologies
Desired experience for associate director, biostatistics includes:
Provide input to product development and performs statistical functions for submission related activities
Provide statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities)
May serve as a primary contact with outside investigators (and vendors) in the preparation of scientific presentations and manuscripts
May interact with external Key Opinion Leaders (KOLs)
Pursue rigorous statistical analyses in support of business-critical new research ideas
Explore and implement innovative statistical methods
Associate Director, Biostatistics Examples
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Associate Director, Biostatistics Job Description
Job Description Example
Our growing company is hiring for an associate director, biostatistics. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate director, biostatistics
- Lead the development of post marketing commitment (PMC) linked regulatory analysis/reports based on the Registry data
- Work closely with the registry teams and external disease experts to lead the design and conduct of innovative epidemiological and biostatistical analyses, of both the natural history of the diseases long-term treatment outcomes
- Provide epidemiologic advice and direction for the design of new registry sub-studies, the ongoing conduct of the registries
- Present work-in-progress and final analyses via teleconference/WebEx meetings or in-person meetings to Registry advisors and internal stakeholders
- Interact directly with Registry investigators to develop hypotheses, analyses, and reports to address key medical questions to improve patient care and therapeutic outcomes
- Develop analysis plans for implementation by Statistical Programming team
- Collaborate with medical communications team to prepare conference abstracts and manuscripts for publication in peer-reviewed scientific journals
- Provide internal and external training on the concepts and methods of epidemiology as applied to rare diseases and their treatment
- Work with external partners including key opinion leaders, external regulatory agencies and advisory committees, and contract research organizations
- Provide strategic biostatistical input at the study level to internal and external clients which ensure the optimal clinical trial design will be implemented
Qualifications for associate director, biostatistics
- Must have a working knowledge of all appropriate relevant regulatory guidance documents
- 10+ years of pharmaceutical/biotech experiences with a PhD degree and 12+ years with an MS degree
- 5+ years of line management experiences
- Advanced and comprehensive knowledge of biomarker-assisted clinical study designs, analysis methodology and data interpretation across theurapeutic areas
- Advanced and comprehensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of biomarker-assisted clinical trials and regulatory submissions across theurapeutic areas
- Experience representing statistics in interactions with regulatory agencies a plus
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Associate Director, Biostatistics Job Description
Job Description Example
Our growing company is looking for an associate director, biostatistics. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for associate director, biostatistics
- Provides input into statistical SOPs and general standardization efforts within the clinical development department
- Supports Regulatory Authority meetings
- Collaborates with the biostatistics management team (other statistical line managers and Executive Director) to provide leadership and direction to the biostatistics group
- Plans/acquires necessary resources and manages those resources to reach established goals
- Plans and appraises performance of direct reports
- Assists and advises the Executive Director to provide leadership and direction to the biostatistics group
- Provides statistical support to other disciplines related to clinical statistics (e.g., HECOR/Epidemiology and publication activities)
- Pursues rigorous statistical analyses in support of business-critical new research ideas
- Explores and implements innovative statistical methods
- Represents department in meetings with regulatory agencies
Qualifications for associate director, biostatistics
- PhD in epidemiology or biostatistics
- At least 3 years postgraduate experience
- At least 5 years of pharmaceutical industry or relevant experience
- Thorough technical knowledge of epidemiology and biostatistics methods
- Experience and familiarity using SAS for statistical analysis
- Track record of high quality publications in peer-reviewed journals
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Associate Director, Biostatistics Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of associate director, biostatistics. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate director, biostatistics
- Ensures availability of integrated database(s) where needed, and planning and conduct of integrated analyses to support development decisions, submissions or marketing needs
- Reviews key project and study documents to ensure optimal statistical presentation and compliance
- With minimal direction from departmental management, assume leadership role for providing statistical support to project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols
- Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations
- Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL
- Oversee production of the statistical analyses according to SAP
- Plan and track project activities, timelines, and resource use
- Provide technical direction and mentoring to staff
- Guides global staff in the preparation of Statistical Analysis Plans
- Participates in project teams for clinical development programs and/or lifecycle management of marketed products
Qualifications for associate director, biostatistics
- Translate problems into mathematical forms and use state-of-the-art modelling techniques to provide solutions
- Direct and ensure the accuracy and timeliness of the vendor’s output
- Support the development and implementation of departmental standards and process improvements to maximize global data integration and interpretability
- Directly be responsible for the statistical integrity, adequacy and accuracy of the clinical studies within the project
- Represent the Biostatistics department in all interactions linked to the project that will take place with the Health Authority
- This role will require strong communications (fluent in English) and influencing skills and great adaptability, interacting with the global project team, leveraging internal and external resources to achieve high quality, timely and cost-effective study deliverables
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Associate Director, Biostatistics Job Description
Job Description Example
Our company is growing rapidly and is looking for an associate director, biostatistics. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate director, biostatistics
- Work as biostatistics function representative in clinical projects and studies
- Manage and analyze information from multiple sources to develop and communicate trends on global and regional levels to provide insights to the BDS quality strategy and ensure oversight and control of quality critical processes in BDS
- Continuously manage and improve quality tracking, monitoring and reporting of quality issues for BDS
- Take the lead on content development of the BDS Quality Newsletter, by collating learnings from non-compliances and audit findings and consulting with Global Process Owners, BDS Training Committee members, BDS Quality Management on other relevant quality topics to be shared with the BDS community via the Newsletter
- Support BDS Quality Management in quality-related meetings to bring forward quality issues for discussion (e.g., CAPA Leads meeting, Training Committee meeting)
- Ensure gBDS materials in Knowledge Management system are maintained according to the gBDS strategy through oversight
- Complete data package relevant for submission or making key decisions
- Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects
- Provide justification for planned resource needs
- Learn and apply techniques to promote teamwork, quality, and motivation
Qualifications for associate director, biostatistics
- Ability to provide effective direction to CROs and Statistical Programmers
- Experience with diabetes studies a plus
- Comprehensive knowledge of clinical trials methodology, regulatory requirements, and statistical software packages
- Advanced degree in biostatistics, statistics, or related field (e.g., pharmacometrics) experience in a regulatory environment within biopharmaceutical product development
- Experience in supporting Phase 1 studies early-phase studies to support development program decisions (“go/no go”) and dose selection
- Demonstrated proficiency initiating and managing clinical trials outsourcing trials and programs
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Associate Director, Biostatistics Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of associate director, biostatistics. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate director, biostatistics
- Work closely with the registry teams and external disease experts to lead the design and conduct of publication-level epidemiological and biostatistical analyses, of both the natural history of the disease long-term treatment outcomes
- Collaborate with SG medical communications team to prepare conference abstracts and manuscripts for publication in peer-reviewed scientific journals
- Interact directly with SG Registry investigators to develop hypotheses, analyses, and reports to address key medical questions to improve patient care and therapeutic outcomes
- Develop analysis plans for implementation by SG Statistical Programming team
- Interact with biostatistics and statistical programming contractors to develop analysis plans and TLFs for certain projects
- Provide consultation to other members of the SG epidemiology/biostats team for the development of post marketing commitment (PMC) linked regulatory analysis/reports and Data Analysis Requests (DAR) based on the Registry data
- Domestic and international travel required to participate in Registry Board of Advisors meetings and other scientific conferences (~10% of time)
- Serve as Epi/Biostat lead for the MPS I Registry
- Lead the development of responses to Data Analysis Requests (DAR) received from Registry investigators, regulators, reimbursement authorities, and internal stakeholders for the MPS I Registry
- Minimum 5 years of hands on Bio-statistics experience in the Pharmaceutical or Biotech industry
Qualifications for associate director, biostatistics
- Ability to explain strategies, approaches, methods, analyses, and findings to non-statistician group members and senior managers
- Experience analyzing data from Immunology (RA, Dermatology, Asthma ) studies
- Ability to support statisticians conducting a submission project, including interactions with regulatory authorities on statistical issues by efficient resource management
- Ability to challenge Trial Statistical Analysis Plans, protocols and clinical trial reports during the review process
- Ability to integrate new hires and prepare development plan
- Must have excellent oral and written presentation skills