VP, Biostatistics & Regulatory Strategy

BioCryst Pharmaceuticals; North Carolina; On-site; USD 230,000 - 350,000; Full time

Job summary

BioCryst Pharmaceuticals seeks a Vice President of Biostatistics to lead core statistical activities for BioCryst-sponsored studies, ensuring high-quality design, analysis, and regulatory compliance.

The role requires a Ph.D. in Biostatistics with 18+ years in pharma, including 5+ years in people management and extensive NDA/BLA experience. Strong communication and global regulatory expertise are essential.

Qualifications

• Ph.D. in Biostatistics with extensive pharma experience.
• 18+ years in pharmaceutical statistics, with 10+ in trials design and interpretation.
• At least 5 years of people management experience.
• Expertise in adaptive clinical trial designs and multiplicity methods.
• NDA/BLA filing experience and regulatory submissions involvement.
• Experience with Data Monitoring Committees or study steering committees.
• Excellent written and verbal communication skills.
• Global regulatory agency experience.
• Proficiency in Bayesian and frequentist statistics.

Responsibilities

• Oversee relevance and accuracy of statistical methods across BioCryst-sponsored studies.
• Lead statistical activities for regulatory submissions (NDA/BLAs).
• Ensure data processing conforms to GCP and regulatory guidelines.
• Lead and mentor junior biostatistics staff.
• Select, direct, and supervise CROs/contract staff.
• Utilize SAS, EAST, and R for internal analyses and sample-size planning.
• Participate in clinical development/product management teams.
• Represent biostatistics in FDA and regulatory meetings.
• Define and monitor key performance metrics.
• Author and review SAPs, protocols, and regulatory documents.

Skills

Biostatistics leadership

Statistical design

Regulatory strategy

Vendor management

SAS/R programming

Regulatory communication

Bayesian stats

Frequentist stats

Clinical trials

Global regulatory

Education

Ph.D. in Biostatistics

Tools

SAS

R

EAST

Job description

BioCryst Pharmaceuticals seeks a Vice President of Biostatistics to lead core statistical activities for BioCryst-sponsored studies, ensuring high-quality design, analysis, and regulatory compliance.

The role requires a Ph.D. in Biostatistics with 18+ years in pharma, including 5+ years in people management and extensive NDA/BLA experience. Strong communication and global regulatory expertise are essential.