Associate Director, Biostatistics
$195.67k - $253.22kGilead
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
Vacancy posted 8 days ago
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