Biostatistics Strategy Leader — Clinical Trials

Gilead Sciences, Inc; Foster City (CA); On-site; USD 196,000 - 253,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Benefits package

Medical, dental, vision, and life ins.

Job summary

Gilead Sciences, Inc. in the San Francisco Bay Area seeks an Associate Director of Biostatistics to provide strategic leadership for clinical development programs within Virology.

You will collaborate with Clinical Development, Safety, Pharmacology, Regulatory Affairs, and Data Management to ensure rigorous planning, analysis, and reporting across multiple studies. The role requires leading statistical design input, SAPs, TFLs and CSR reviews, and contributing to publications and regulatory

Qualifications

• Bachelor's Degree and 10 years’ experience
• Master's Degree and 8 years’ experience
• PhD /PharmD and 5 years’ experience
• Demonstrated ability to rapidly assimilate scientific and statistical information.
• Has advanced knowledge of biomedical statistical analysis and trial design.

Responsibilities

• Serve as lead statistician for Phase 1–3 clinical trials with responsibility for overall statistical strategy and delivery
• Acts as biostatistics lead on clinical studies or other non-molecule projects
• Represent Biostat on study management teams and development teams, providing strategic statistical leadership
• Provides statistical consultation on trial design, endpoints, analysis methods, and authors statistical analysis plans
• Oversees and leads technical and operational statistical activities for multiple trials
• Contributes to cross-functional development planning and protocol development
• Reviews and analyzes safety reporting and biomarker analyses to inform decisions
• Uses advanced statistical methods to analyze historical and external data for development
• Provides biostatistical input into publications and regulatory documents
• Participates in special projects to improve methodologies and SOPs
• Adheres to regulatory requirements and SOPs

Skills

Biostatistics leadership

Clinical trial statistics

Regulatory knowledge

Statistical analysis plans

Cross-functional collaboration

Statistical software usage

Education

Bachelor's Degree

Master's Degree

PhD/PharmD

Job description

Gilead Sciences, Inc. in the San Francisco Bay Area seeks an Associate Director of Biostatistics to provide strategic leadership for clinical development programs within Virology.

You will collaborate with Clinical Development, Safety, Pharmacology, Regulatory Affairs, and Data Management to ensure rigorous planning, analysis, and reporting across multiple studies. The role requires leading statistical design input, SAPs, TFLs and CSR reviews, and contributing to publications and regulatory