VP Biostatistics — Strategy, Regulatory Leadership

BioCryst Pharmaceuticals; Massachusetts; On-site; USD 200,000 - 320,000; Full time

Job summary

BioCryst Pharmaceuticals seeks a Vice President of Biostatistics to lead statistical strategy across clinical development programs, ensure GCP conformance, and guide regulatory submissions. The role requires extensive study design, regulatory experience, and the ability to direct a global biostatistics team.

The position emphasizes leadership, strategic thinking, and collaboration with cross-functional teams to advance BioCryst’s therapeutic programs in rare diseases.

Qualifications

• Ph.D. in Biostatistics (or related field) with at least 18 years' experience in the pharmaceutical industry.
• At least 5 years of people management and leadership role.
• Experience with NDA/BLA filings and regulatory strategy.
• Expertise in Bayesian and frequentist statistics.

Responsibilities

• Oversee statistical activities for BioCryst-sponsored clinical development and selected nonclinical studies.
• Lead and manage junior biostatistics staff and CRO/vendor teams.
• Contribute to clinical development strategies and study design.
• Communicate technical concepts to regulatory and nontechnical audiences.

Skills

Biostatistics

Clinical trial design

Regulatory submissions

Leadership

Bayesian statistics

Frequentist statistics

Statistical software

Education

PhD in Biostatistics

Tools

SAS

R

EAST

Job description

BioCryst Pharmaceuticals seeks a Vice President of Biostatistics to lead statistical strategy across clinical development programs, ensure GCP conformance, and guide regulatory submissions. The role requires extensive study design, regulatory experience, and the ability to direct a global biostatistics team.

The position emphasizes leadership, strategic thinking, and collaboration with cross-functional teams to advance BioCryst’s therapeutic programs in rare diseases.