Director, Biostatistics

Role: Lead statistical strategy and execution for Phase 1-3 clinical trials in inflammation and oncology, ensuring high-quality deliverables and regulatory compliance. Responsibilities: design and analyze studies, author key statistical documents, oversee CRO activities, review datasets and reports, support regulatory submissions, and mentor statistical programming teams. Requirements: PhD in Biostatistics, Statistics, or related field; 15+ years supporting clinical drug development; extensive experience in CRO-heavy models, regulatory standards (FDA, ICH), and clinical trial statistics; proficiency in SAS. HighValue: oncology and inflammatory indications, early to late-phase trials, CRO management, statistical programming oversight, and active involvement in regulatory interactions.