Executive Director, Biometrics & Clinical Statistics

BioCryst Pharmaceuticals; North Carolina; On-site; USD 220,000 - 320,000; Full time

Job summary

BioCryst Pharmaceuticals is seeking an Executive Director, Biometrics, to lead the design and analysis of BioCryst-sponsored clinical studies from Phase I to IV, and selected non-clinical work. This role requires deep biostatistics expertise, vendor management, and the ability to communicate complex methods clearly.

The position emphasizes regulatory conformance, advanced statistical thinking, and the development of new processes in biostatistics and programming, with opportunities to influence

Qualifications

• Ph.D. in Biostatistics with at least 12 years in pharma.
• Deep experience in design, analysis and interpretation of clinical trials.
• SAS programming oversight and hands-on capability.
• NDA filing experience with product approvals.
• Knowledge of regulatory guidelines and GCP.
• Strong leadership and communication skills.

Responsibilities

• Provide Biometrics support for BioCryst-sponsored clinical studies and selected non-clinical studies.
• Ensure relevance and adequacy of statistical methods in development activities.
• Ensure conformance to regulatory guidelines and GCP.
• Contribute to clinical development strategies and study design.
• Oversee CRO/contract staff and contracts; review invoices.
• Act as project statistician for individual projects.

Skills

Biostatistics

Leadership

Communication skills

Bayesian statistics

Frequentist statistics

SAS programming

Education

Ph.D. in Biostatistics

Tools

SAS programming

Job description

BioCryst Pharmaceuticals is seeking an Executive Director, Biometrics, to lead the design and analysis of BioCryst-sponsored clinical studies from Phase I to IV, and selected non-clinical work. This role requires deep biostatistics expertise, vendor management, and the ability to communicate complex methods clearly.

The position emphasizes regulatory conformance, advanced statistical thinking, and the development of new processes in biostatistics and programming, with opportunities to influence