Associate Director, Biostatistics

Role: Provide statistical leadership for clinical development programs from study design to regulatory submission, acting as a key partner to cross-functional teams. Responsibilities: lead statistical activities including protocol and SAP development, data analysis, interpretation, and support for regulatory interactions; oversee CRO deliverables; contribute to statistical standards and team development. Requirements: PhD or MS in Biostatistics or related field; 5+ years (PhD) or 8+ years (MS) industry experience; expertise in clinical trial design, statistical methodology, regulatory principles, and proficiency with SAS; strong communication skills; ability to manage multiple projects independently. HighValue: experience with NDA/BLA submissions, clinical trials in biotech/pharma settings, and hands-on statistical analysis. WorkSetup: not specified.