Associate Director, Biostatistics- Virology

Gilead Sciences • Foster City, CA

24d • Hybrid

About The Position

The Associate Director, Biostatistics provides strategic and operational statistical input for clinical development programs within Gilead’s Virology Therapeutic Area. The role serves as lead statistician for Phase 1–3 clinical trials, representing Biostatistics on study management and development teams and collaborating with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, Clinical Data Management, and other Biostatistics colleagues. Responsibilities include statistical input on study design, clinical development plans, sample size determination, protocol development, statistical analysis plans, tables, figures and listings (TFLs), clinical study reports (CSRs), scientific publications and presentations, and regulatory requests. The role may also lead or contribute to department initiatives and working groups not tied to a specific molecule.

This is an on-site/hybrid position requiring the employee to work on site three days per week. The position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary by role), paid time off, and company-sponsored medical, dental, vision, and life insurance plans.

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.
• Experience using advanced statistical software, methods, and techniques.
• Ability to provide statistical input on clinical trial design, analysis, interpretation, and reporting.

Nice To Haves

• 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 teams and development teams, providing strategic statistical input and collaborating with Biostatistics colleagues and cross-functional teams.
• Provide statistical consultation on trial design, endpoints, 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 statistical 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.
• Contribute to department strategic initiatives or working groups that are not molecule-based.
• Create an inclusive environment and embed the value of diversity in team management.
• Develop talent by coaching employees, providing feedback, and supporting their performance and growth.
• Empower teams by aligning goals and organizational objectives, holding teams accountable, removing barriers, and connecting them to the broader organization.

Benefits

• Discretionary annual bonus may be available.
• Discretionary stock-based long-term incentives may be available; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed