Executive Director, Statistical Programming

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Create a vision and strategy for BioCryst’s statistical programming team.

• Supervise statistical programming tasks for all BioCryst clinical trials, including both in-house and outsourced efforts.

• Lead analyses for regulatory submissions, safety evaluations, scientific publications, and medical affairs.

• Manage statistical programmers and guarantee strong technical skills for complex algorithms and regulatory submission materials.

• Identify software and system needs for the Biometrics and Data Science team in collaboration with Information Technology.

• Stay updated on industry best practices and standards.

• Engage in capacity planning and departmental expansion.

• Provide statistical programming leadership and consistent support for all clinical study teams.

• Ensure the completeness, accuracy, and timeliness of statistical programming for clinical development activities and certain nonclinical studies.

• Oversee outsourced statistical programming and maintain regular meetings with CRO counterparts.

• Review eCRFs, annotated CRFs, data management plans, edit check specifications, and statistical analysis plans.

• Ensure precise programming of tables, listings, and figures.

• Collaborate with data management on compliance with regulatory guidelines and Good Clinical Practice.

• Offer specialized SAS programming and tailored line listings for clinical data review.

• Provide training and support on internal data review tools.

• Select, guide, and oversee CRO/contract personnel.

• Maintain study documentation in accordance with SOPs and audit standards.

• Define, develop, and implement organization-wide processes aimed at enhancing efficiency and productivity.

• Author SOPs pertinent to statistical programming.

• Monitor and assess performance metrics.

• Communicate technical concepts to technical, regulatory, and broader non-technical audiences.

• Undertake additional duties as assigned.

⛳️ Requirements

• M.S. in Biostatistics, Computer Science, or a related field with a minimum of 15 years’ experience in the pharmaceutical industry, including relevant experience in analyzing clinical trial data, or an equivalent combination of education and experience.

• Extensive experience in SAS programming.

• Previous experience in NDA/BLA submissions to effectively support product approvals.

• Prior experience in managing permanent staff.

• Experience with SAS/Graph and/or providing high-quality graphics for scientific publications.

• Familiarity with 21 CFR Part 11 standards.

• Experience with tools that facilitate data viewing by medical monitors and others.

• Prior experience in managing outsourced statistical programming projects.

• Proven knowledge in statistical programming disciplines, practices, and procedures.

• Understanding of clinical data management processes.

• Demonstrated knowledge of the clinical development process and relevant regulatory guidelines and requirements.

• Awareness of the roles and responsibilities within Biostatistics and Data Management.

• Leadership skills in both functional and cross-functional contexts.

• Hands-on approach to statistical analyses.

• Outstanding written and verbal communication abilities.

• Capability to work effectively in a collaborative environment and challenge the status quo.

• Responsiveness and the ability to prioritize effectively.

• Experience with early-phase clinical trials and clinical pharmacology endpoints is advantageous but not mandatory.

• Knowledge of clinical database design would be beneficial.

🏝️ Benefits

• Equal employment opportunities regardless of age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability, and/or other protected class characteristics.

• Compliance with all federal, state, and local laws.