Associate Director, Biostatistics

This role leads biostatistical strategy and operations for clinical development programs within the Virology Therapeutic Area. The Associate Director will serve as the statistical lead for Phase 1–3 trials, represent biostatistics on cross-functional teams, and provide strategic input on study design, analysis plans, and regulatory submissions across multiple molecules and programs.

Responsibilities

• Lead statistical strategy and delivery for Phase 1-3 clinical trials
• Represent biostatistics on study management and development teams across multiple projects
• Author statistical analysis plans, oversee trial designs, sample size determination and protocol development
• Direct internal and external teams in statistical activities for clinical trials and marketed products
• Review safety reporting and biomarker analyses to inform development decisions

Requirements

• Bachelor's degree with 10+ years experience, or Master's with 8+ years, or PhD/PharmD with 5+ years
• Advanced biomedical statistical analysis knowledge with independence in designing multiple strategies
• FDA, EMA regulations, ICH guidelines, GCP and clinical procedures familiarity
• Strong written and verbal communication, collaboration and organizational skills
• Knowledge of drug development phases and associated clinical trial design
• HBV and HIV program experience preferred