Associate Director, Biostatistics
Core
Provide strategic and operational statistical leadership for clinical development programs in the Virology Therapeutic Area, ensuring high-quality statistical planning, analysis, and reporting for Phase 1–3 trials.
Role type
Senior IC Associate Director Biostatistics (Virology)
Builds
Clinical development plans, statistical analysis plans, regulatory documentation, and scientific publications for virology therapies.
Domain
Biopharmaceuticals / Clinical Trials / Virology
Required skills
Strategic statistical leadership, clinical trial design (Phase 1–3), sample size determination, protocol development, SAP authoring, regulatory compliance (FDA/EMA/ICH/GCP), team management, cross-functional collaboration, advanced statistical software proficiency.
Preferred skills
Virology domain expertise, innovative trial design knowledge, SOP development, resource management, scientific publication authoring.
Technologies
SAS, R, Python, SQL, Biostatistical software packages
Responsibilities
Lead statistical strategy and delivery for Phase 1–3 clinical trials; represent Biostatistics on study management and development teams; provide statistical consultation on trial design, endpoints, and analysis methods; oversee technical and operational statistical activities for multiple molecules or products; advise on statistical analysis strategies and interpretation of results; review safety reporting and biomarker analyses; contribute to regulatory submissions and scientific publications.
Seniority
Senior, hands-on IC with leadership responsibilities