Exec. Director, Statistical Programming

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.

About the role

The Executive Director, Statistical Programming within BioCryst Pharmaceuticals is responsible for leading the statistical programming group at BioCryst. This includes providing oversight of statistical programming activities for all BioCryst clinical trials, including both in-house and outsourced activities. Examples of programming activities include analyses for submission to regulatory agencies, exploratory work to support safety review and other activities, and analyses to support scientific publications and medical affairs. He/she must be a strong leader with extensive experience in the use of SAS software for analysis of clinical trial data and thorough knowledge of CDISC standards. Having both technical, line management and vendor oversight responsibilities, the person in this role is responsible for statistical programming strategy, conduct of analyses, and conformance to principles of GCP as applicable to biostatistics, statistical programming, and clinical data management. An understanding of how SAS programming can be used to support data management activities would be needed. Performance in this role relies on significant experience in analysis of clinical trial data as well as sound judgment to plan and accomplish goals in a small-company environment.

Responsibilities

• Responsible for developing a vision and strategy for statistical programming group at BioCryst
• Responsible for Biometrics and Data Science group’s software and systems needs, in partnership with Information Technology.
• Manages a group of statistical programmers and ensures the team has the best technical capabilities for managing complex algorithms and sophisticated regulatory submission packages.
• Keep abreast of industry best practices and standards used
• Participates in capacity planning, including planning for departmental growth as well as increases in capability for in-house programming
• Ensures that all clinical study teams have a statistical programming lead and that consistent support is provided to each team.
• Ensures the completeness, accuracy and timeline of statistical programming employed in BioCryst-sponsored clinical development activities and selected nonclinical studies.
• Ensures oversight of statistical programming for outsourced trials and regularly meets with CRO counterparts.
• Ensures consistent and quality review of the following items by statistical programming: eCRFs, annotated CRFs, data management plan, edit check specifications, and statistical analysis plan, with a view to ensuring that data required for specified analyses will be collected, clean, and can be appropriately analyzed.
• Ensures accurate programming of internally-produced tables, listings, figures
• In collaboration with data management, ensures clinical data conformance to relevant regulatory guidelines and Good Clinical Practice. For example, may provide specialty SAS programming for data management customized line listings to support review of clinical trial data.
• Ensures training and support is provided for programmers, medical monitors