Job Description
📋 Description Operational leadership of global biostatistics and programming teams. Regulatory interactions; align statistical strategy with guidelines. Strategic input in CDPs, protocols, IBs, regulatory docs, and pubs. Statistical integrity: SAP development and execution ensuring data integrity. Radiopharmaceutical and BRC support incl imaging endpoints and dosimetry. CRO & Vendor management: oversight of external programming deliverables. 🎯 Requirements PhD or Masters with leadership in biometrics. Oncology drug development Ph I-III; radiopharmaceutical/imaging experience. Regulatory acumen: ICH, FDA, EMA; present strategies to regulators. Advanced statistics: adaptive designs, Bayesian methods, master protocols. Technical: SAS, R, Python; CDISC standards; submission readiness. Leadership: collaborative, cross-functional, fast-paced. 🎁 Benefits 401(k) with 4% match and immediate vesting. Comprehensive health benefits for you and family. FSAs (Health and Dependent Care); EAP. Paid time off, holidays, and potential additional days. Annual bonus program and equity options. Flexible working environment and supportive culture.
