Exec. Director, Statistical Programming

Role: Executive Director, Statistical Programming at BioCryst, overseeing the global statistical programming group supporting clinical trials and regulatory submissions. Responsibilities include developing strategy, managing internal and outsourced programming teams, ensuring quality and compliance of analyses, and supporting regulatory filings like NDA/BLA. Ensures data conformance to GCP and FDA standards, collaborates with Data Management, CROs, and cross-functional teams, and maintains SOPs and performance metrics. Qualifications: MS in Biostatistics, Computer Science, or related field; 15+ years in pharma/biotech, extensive SAS programming experience, and prior NDA/BLA support. Preferred: experience in early-phase trials, graphics for publications, and managing vendors. High-value specifics: expertise in clinical trial data analysis, GxP compliance, regulatory standards (21CFR Part 11), and leadership in small-company environments. Work setup: leadership role with hands-on responsibilities, in a global biopharma context, with no specific travel mentioned.