Director/Associate Director Biostatistics

Role: Associate Director or Director of Biostatistics supporting oncology and rare disease drug development from Phase 1 to Phase 3. Responsibilities: lead statistical strategies, trial design (including pediatric and small populations), and innovative methodologies for rare diseases; author key regulatory documents; oversee statistical deliverables and CRO/vendor management; collaborate with cross-functional teams; and support regulatory interactions. Qualifications: Ph.D. (preferred) or M.S. in Statistics/Biostatistics with 8+ years of drug development experience; expertise in oncology, pediatrics, or rare diseases; proficiency in SAS/R; experience managing CROs; strong communication and strategic skills. High-Value: focus on oncology and rare diseases, early to late-phase clinical trials, regulatory documentation, statistical innovation, and cross-functional leadership. Work setup: Remote with up to 20% travel.