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 biostatistician (Associate Director)
Builds
Clinical development plans, statistical analysis plans (SAPs), clinical study reports (CSRs), and scientific publications for virology therapies.
Domain
Biopharmaceuticals / Clinical Trials / Virology
Required skills
Statistical strategy design, sample size determination, protocol development, SAP authoring, CSR review, safety reporting analysis, biomarker analysis, regulatory compliance (FDA/EMA/ICH/GCP), team leadership, project management
Preferred skills
Virology domain expertise, innovative trial design knowledge, advanced statistical software proficiency, cross-functional collaboration, SOP development
Technologies
SAS, R, Python, SQL, CDISC standards
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 result interpretation; review safety reporting and biomarker analyses; contribute to scientific publications and regulatory documentation; lead or participate in special projects and SOP implementation.
Seniority
Senior, hands-on IC with leadership responsibilities
