Associate Director, Biostatistics- Virology
About The Position
The Associate Director, Biostatistics provides strategic and operational statistical input for clinical development programs in the Virology Therapeutic Area. The role serves as lead statistician for Phase 1–3 clinical trials and represents Biostatistics on study management and development teams. It works closely with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, Clinical Data Management, and other Biostatistics colleagues to support high-quality statistical planning, analysis, interpretation, and reporting. The position contributes statistical strategy to study design and clinical development plans, sample size determination, protocol development, statistical analysis plans, tables, figures, and listings (TFLs), clinical study report (CSR) review, scientific publications and presentations, and regulatory requests. The role may also lead or contribute to non-molecule-based activities, including department strategic initiatives and working groups. The position is on site/hybrid and requires working on site three days per week.
Requirements
- 10 or more years of relevant experience with a BS/BA, or 8 or more years with an MS/MA or MBA, or 5 or more years with a PhD.
Nice To Haves
- A PhD is strongly preferred.
Responsibilities
- Serve as lead statistician for Phase 1–3 clinical trials, with responsibility for overall statistical strategy and delivery.
- Represent Biostatistics on study management and development teams, providing strategic statistical input and collaborating with Biostatistics colleagues and cross-functional teams.
- Consult on trial design, endpoints, and analysis methods, and author statistical analysis plans.
- Advise internal and external partners, where applicable, on statistical analysis strategies, measurement reliability, model identifiability, and interpretation and presentation of results.
- Use advanced statistical software, methods, and techniques to gather, analyze, and interpret historical and external data for clinical development.
- Provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory documentation.
- Adhere to regulatory requirements for study conduct, statistical analysis principles, industry standards, and Gilead standard operating procedures.
- Potentially lead or contribute to department strategic initiatives and working groups.
- As a people leader, create inclusion, develop talent, and empower teams.
Benefits
- May be eligible for a discretionary annual bonus.
- May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
- 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
No Education Listed
