Senior Manager, Biostatistics

Role: Senior Manager, Biostatistics, providing statistical leadership for complex clinical studies in cell therapy oncology, primarily supporting TIL therapies. Responsibilities: lead statistical activities for clinical trials, collaborate with CROs, authors and review regulatory and scientific documents, contribute to statistical strategy, and ensure high-quality deliverables. Qualifications: Ph.D. in Statistics/Biostatistics or M.S. with 6–8 years industry experience, strong oncology clinical development background, expertise in survival analysis, patient-reported outcomes, and health economics; proficiency in SAS and familiarity with R. Preferred: knowledge of FDA, EMA, ICH guidance, and experience supporting regulatory submissions (NDA/BLA/MAA). HighValue: oncology (solid tumors), cell therapy, TIL platform, early- and late-phase trials, regulatory interactions, remote work. Collaboration: cross-functional teams, CRO partners, internal and external stakeholders. WorkSetup: remote.