Head of Statistical Programming & Data Strategy

BioCryst Pharmaceuticals; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

BioCryst Pharmaceuticals in Durham, NC seeks an Executive Director of Statistical Programming to lead the Biostatistics and Data Science group, oversee in-house and outsourced trials, and drive regulatory submissions using SAS and CDISC standards.

You will manage a team of programmers, collaborate across functions, ensure GCP compliance, and mentor staff while shaping programming strategy for high-impact clinical development in a small-company environment.

Qualifications

• M.S. in Biostatistics, Computer Science or related field with 15+ years in pharma, plus extensive SAS programming experience.
• Experience with NDA/BLA submissions to support approvals.
• Experience managing permanent staff.
• Experience with SAS/Graph and providing quality graphics for publications.
• Understanding of 21 CFR Part 11 and regulatory expectations.

Responsibilities

• Develop a vision and strategy for the statistical programming group.
• Oversee software and systems needs in partnership with IT.
• Manage a team of statistical programmers and ensure technical capabilities.
• Ensure complete and timely statistical programming for all studies and submissions.
• Oversee CRO/contract staff for outsourced programming.
• Ensure documentation meets SOP and audit standards.

Skills

Leadership

Communication

Team leadership

Hands-on

Cross-functional collaboration

Prioritization

Education

M.S. in Biostatistics/Statistics/related

Tools

SAS programming

SAS/Graph

Job description

BioCryst Pharmaceuticals in Durham, NC seeks an Executive Director of Statistical Programming to lead the Biostatistics and Data Science group, oversee in-house and outsourced trials, and drive regulatory submissions using SAS and CDISC standards.

You will manage a team of programmers, collaborate across functions, ensure GCP compliance, and mentor staff while shaping programming strategy for high-impact clinical development in a small-company environment.