Associate Director, Biostatistics
About The Position
Support biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring statistical analysis plans and providing biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings. Dependent upon the area of assignment, you may contribute to the projects or other activities, such as Biostatistics tools, programming, centralized analyses and reporting, etc. You will also contribute to short- and long-range Biostatistics strategies, plans and infrastructure development that transcend multiple areas and teams across Biostatistics, such as team capability development.
Requirements
- PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience OR MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 8+ years of relevant experience OR BS/BA in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 10+ years of relevant experience
Nice To Haves
- PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline with 2+ years of relevant experience
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Has knowledge of biomedical statistical analysis, best practices and tools and has shown ability to apply this to improve overall results.
- Understands drug development phases and the nature of associated clinical trials across phases.
- Strong scientific judgment and ability to interpret complex data clearly.
- Strong communication and organizational skills.
- Experience developing software and other tools to support statistical analysis of biomedical or related data.
- Strong proficiencies in SAS and R.
- Proven effectiveness managing projects.
- When needed, ability to travel.
Responsibilities
- Provides support to statistical analysis, document review and data inclusion for NDA submissions of assigned studies by collaborating with other Biostatistics team members and cross-functional partners.
- Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans.
- Depending on area of assignment, may lead projects or other activities that are non-study based, such as Biostatistics tools, programming, centralized analyses and reporting, etc.
- Contributes to cross-functional clinical development planning for one or more studies; provide the biostatistical perspective and biostatistical input.
- Contributes to gathering, organization and analysis of different data sources to enable delivery of the statistical analysis plan and clinical study endpoints for assigned products.
- Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for clinical development.
- Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and Gilead SOPs.
Benefits
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
