VP, Biometrics

📋 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.