Associate Director, Biostatistics

Gilead

Gilead Sciences seeks an Associate Director of Biostatistics to provide strategic statistical leadership for clinical development programs in the Virology Therapeutic Area. The role involves leading Phase 1–3 clinical trials, collaborating with cross-functional teams, and ensuring high-quality statistical planning and regulatory compliance.

Responsibilities

Serve as lead statistician for Phase 1–3 clinical trials with overall statistical strategy responsibility
Represent biostatistics on study management and development teams, providing strategic leadership
Develop and author statistical analysis plans, determine sample sizes, and review protocols
Oversee technical and operational statistical activities for multiple clinical trials and direct internal/external teams
Provide biostatistical input on study design, safety reporting, and regulatory documentation

Requirements

Bachelor's degree and 10 years of biostatistics or clinical trial experience
Master's degree and 8 years of relevant experience, or PhD and 2 years experience
Advanced knowledge of biomedical statistical analysis and drug development phases
Familiarity with FDA, EMA regulations, ICH guidelines, and GCP standards
Strong written and verbal communication and project management skills
Experience in virology and innovative trial designs preferred

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Vacancy posted 5 days ago

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