Sr Director, Biostatistics
Gilead Sciences
6 months ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Sr Director, Biostatistics (Oncology)
Responsibilities
- Provide strategic statistical leadership for late-stage (Phase 3) oncology clinical trials, including design optimization and quantitative decision support.
- Serve as statistical lead for assigned oncology molecules/indications; represent Biostatistics in Health Authority interactions and ensure alignment/accountability with the Therapeutic Area Head.
- Partner cross-functionally (Statistical Programming, Clinical Research, Data Management, Clinical Operations, Global Drug Safety, Regulatory, Project Management) to deliver analyses and clinical reports on time and to standard.
- Apply statistical/regulatory principles to meet scientific, regulatory, and business objectives; support regulatory strategy/risk assessment; contribute to publications and external presentations while managing timelines/resources.
- Lead, mentor, and develop teams of statisticians (staffing strategy, succession planning, long-term workforce planning).
- Use competitive intelligence and external scientific/regulatory networks to inform development strategy.
- Demonstrate strong judgment and communication to drive alignment across functions.
Qualifications
- PhD (12+ years) or MS (14+ years) in biostatistics/statistical analysis in pharma/biotech; at least 5 years in oncology drug development.
- Hands-on oncology clinical development experience, including design/analysis of Phase 3 trials and leadership of NDA and/or BLA submissions.
- Experience interacting with global Health Authorities; contribution to regulatory strategy/labeling.
- Proficiency with industry-standard statistical software and current methodologies.
- Proven people-management experience.
People leader accountabilities: create inclusion, develop talent, empower teams.
Compensation/Benefits (as stated)
- Salary range: Bay Area $261,375–$338,250; Other US locations $237,575–$307,450. May be eligible for annual bonus, stock-based incentives, paid time off; medical/dental/vision/life insurance.
Application
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities
- Provide strategic statistical leadership for late-stage (Phase 3) oncology clinical trials, including design optimization and quantitative decision support.
- Serve as statistical lead for assigned oncology molecules/indications; represent Biostatistics in Health Authority interactions and ensure alignment/accountability with the Therapeutic Area Head.
- Partner cross-functionally (Statistical Programming, Clinical Research, Data Management, Clinical Operations, Global Drug Safety, Regulatory, Project Management) to deliver analyses and clinical reports on time and to standard.
- Apply statistical/regulatory principles to meet scientific, regulatory, and business objectives; support regulatory strategy/risk assessment; contribute to publications and external presentations while managing timelines/resources.
- Lead, mentor, and develop teams of statisticians (staffing strategy, succession planning, long-term workforce planning).
- Use competitive intelligence and external scientific/regulatory networks to inform development strategy.
- Demonstrate strong judgment and communication to drive alignment across functions.
Qualifications
- PhD (12+ years) or MS (14+ years) in biostatistics/statistical analysis in pharma/biotech; at least 5 years in oncology drug development.
- Hands-on oncology clinical development experience, including design/analysis of Phase 3 trials and leadership of NDA and/or BLA submissions.
- Experience interacting with global Health Authorities; contribution to regulatory strategy/labeling.
- Proficiency with industry-standard statistical software and current methodologies.
- Proven people-management experience.
People leader accountabilities: create inclusion, develop talent, empower teams.
Compensation/Benefits (as stated)
- Salary range: Bay Area $261,375–$338,250; Other US locations $237,575–$307,450. May be eligible for annual bonus, stock-based incentives, paid time off; medical/dental/vision/life insurance.
Application
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.