Exec. Director, Biometrics

Role: Executive Director, Biometrics, leading design, analysis, and oversight of all Phase I-IV clinical studies and select non-clinical studies at BioCryst, primarily in rare diseases like hereditary angioedema. Responsibilities: ensure appropriate statistical methods, regulatory compliance (GCP), contribute to clinical development strategies, oversee CROs, act as project statistician, participate in regulatory meetings, author and review key documents (protocols, SAPs, regulatory submissions), and support scientific communication. Qualifications: Ph.D. in Biostatistics or related field, 12+ years in pharma, deep expertise in clinical trial design, statistical programming (SAS), Bayesian and frequentist methods, with leadership experience and NDA contribution. HighValue: rare disease therapeutics, early to late-phase trials, regulatory interactions (FDA, EU, Japan), GxP compliance, biometrics leadership, post-marketing studies, international travel, and cross-functional collaboration. WorkSetup: flexible, international travel expected.