Senior Director, Biostatistics & Clinical Strategy

BioCryst Pharmaceuticals; North Carolina; On-site; USD 180,000 - 260,000; Full time

Job summary

BioCryst Pharmaceuticals, based in Durham, NC, seeks an Exec. Director, Biostatistics to oversee the design, analysis, and interpretation of BioCryst-sponsored studies from Phase I to IV. This role requires strong leadership, regulatory acumen, and vendor management across global projects.

The candidate will guide statistical thinking, implement new processes in biostatistics, and act as a company spokesperson on statistical topics during regulatory interactions and internal reviews.

Qualifications

• Ph.D. in Biostatistics (or related field) with at least 12 years' pharma experience.
• Deep understanding of SAS programming and ability to oversee statistical programming.

Responsibilities

• Lead Biostatistics support for BioCryst-sponsored studies from Phase I to IV and selected non-clinical studies.
• Ensure statistical methods are appropriate and compliant with GCP.
• Oversee CRO/contract staff and manage outsourcing contracts and invoices.
• Contribute to development strategies, study design, and regulatory discussions.
• Communicate complex statistical concepts to regulatory and nontechnical audiences.

Skills

Biostatistics leadership

Clinical trial design

SAS programming

Regulatory engagement

Vendor management

Education

PhD in Biostatistics

Tools

SAS

Job description

BioCryst Pharmaceuticals, based in Durham, NC, seeks an Exec. Director, Biostatistics to oversee the design, analysis, and interpretation of BioCryst-sponsored studies from Phase I to IV. This role requires strong leadership, regulatory acumen, and vendor management across global projects.

The candidate will guide statistical thinking, implement new processes in biostatistics, and act as a company spokesperson on statistical topics during regulatory interactions and internal reviews.