COMPANY:
At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram .
JOB SUMMARY:
The Director, Statistical Programming, is responsible for the technical leadership and delivery of statistical programming for complex clinical studies and NDA/BLA submissions. The role provides study- and submission-level programming leadership across internally performed and outsourced work, including complex efficacy and safety analyses, integrated summaries, regulatory response analyses, exploratory analyses, publications, and medical affairs deliverables. The incumbent must demonstrate sophisticated SAS programming expertise, strong command of CDISC standards, and extensive experience planning, producing, validating, and defending submission-ready datasets and outputs.
The Director will lead through technical expertise, cross-functional influence, and rigorous oversight of contractors and CRO programming deliverables. Success requires sound judgment, practical problem solving, and the ability to work hands-on in a fast-paced environment while maintaining inspection-ready quality and regulatory compliance.
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Provides technical programming strategy for assigned complex studies, programs, and regulatory submissions, including fit-for-purpose use of programming languages, tools, standards, and systems.
• Provides technical direction, mentoring, and peer consultation as needed.
• Assesses programming scope, complexity, resource needs, critical-path activities, and delivery risks for assigned studies and submissions; recommends an appropriate mix of internal, contractor, and CRO support.
• Acts as the statistical programming lead for assigned studies, development programs, and submission workstreams, ensuring consistent, timely, and technically rigorous support.
• Ensures completeness, accuracy, traceability, reproducibility, and regulatory readiness of statistical programming deliverables for assigned BioCryst-sponsored clinical development activities and selected nonclinical studies.
• Provides hands-on oversight of outsourced programming, including defining specifications and deliverable expectations, reviewing CRO or contractor work, resolving technical issues, tracking risks and dependencies, and holding vendors accountable for quality and timelines.
• Performs expert programming review of eCRFs, annotated CRFs, data management plans, edit-check specifications, statistical analysis plans, dataset specifications, and TLF shells to ensure required data are collected, analysis-ready, traceable, and fit for the intended analyses.
• Develops and validates complex, high-quality tables, listings, and figures, including nonstandard analyses, advanced data visualizations, and time-critical regulatory outputs.
• Collaborates with Biostatistics, Data Management and other functions to support clinical data conformance with applicable regulatory requirements and Good Clinical Practice, including specialized programming and customized review listings as needed.
• Provides technical consultation and training to programmers, medical monitors, scientists, and medical writers on programming standards, data review tools, analysis datasets, and interpretation of outputs.
• Participates in selection and…