VP, Biostatistics

Role: Vice President of Biostatistics at BioCryst, responsible for overseeing statistical design, analysis, and regulatory submission support for clinical development programs targeting rare diseases such as hereditary angioedema. Responsibilities include leading biostatistics strategy, supervising staff and CROs, ensuring GCP compliance, contributing to regulatory dossiers (NDAs/BLAs), and driving process improvements. Requirements: Ph.D. in Biostatistics or related field, 18+ years in pharma, with 10+ years in clinical trial design, analysis, and regulatory submission; 5+ years of leadership experience; expertise in adaptive designs, Bayesian methods, and regulatory interactions. High-Value: Extensive experience with NDA/BLA filings, global regulatory agencies, and real-world evidence; strong communication skills for technical and non-technical audiences; hands-on analysis capability. Work Setup: Not specified.