VP, Biostatistics — Global Clinical Statistics Leader

BioCryst Pharmaceuticals, Inc.; Massachusetts; Hybrid; USD 220,000 - 320,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. invites a seasoned Vice President of Biostatistics to lead statistical strategy acrossBioCryst-sponsored study design, analysis and regulatory interactions. The role requires managing biostatistics teams and external CROs, ensuring GCP compliance and high-quality deliverables.

The candidate will drive regulatory support, develop innovative statistical methods, and mentor staff while aligning with company objectives in rare disease research.

Qualifications

• Ph.D. in Biostatistics (or related field) with extensive pharmaceutical industry experience and leadership.
• Experience in design, analysis and interpretation of clinical trials.
• Proven NDA/BLA filing experience and regulatory interaction.
• Expertise in Bayesian and frequentist statistical methods.
• Experience with regulatory submissions and quality systems.

Responsibilities

• Oversee statistical methods for BioCryst-sponsored clinical development activities.
• Lead regulatory submissions for NDA/BLAs and contribute to regulatory strategy.
• Manage junior biostatistics staff and CRO/contract staff.
• Communicate statistical concepts to technical and regulatory audiences.
• Contribute to process improvements and efficiency in biostatistics.

Skills

Leadership

Regulatory strategy

Statistical design

Communication

Bayesian statistics

Frequentist statistics

Education

Ph.D. in Biostatistics

Tools

SAS

EAST

R

Job description

BioCryst Pharmaceuticals, Inc. invites a seasoned Vice President of Biostatistics to lead statistical strategy acrossBioCryst-sponsored study design, analysis and regulatory interactions. The role requires managing biostatistics teams and external CROs, ensuring GCP compliance and high-quality deliverables.

The candidate will drive regulatory support, develop innovative statistical methods, and mentor staff while aligning with company objectives in rare disease research.