Senior VP, Biostatistics & Regulatory Strategy

BioCryst Pharmaceuticals, Inc.

North Carolina

Sur place

USD 250 000 - 320 000

Plein temps

Il y a 2 jours

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Résumé du poste

BioCryst Pharmaceuticals, Inc. seeks a Vice President of Biostatistics to lead planning and delivery of statistical activities across BioCryst-sponsored studies, ensuring high-quality design, conduct, and analysis in line with GCP.

The role combines managerial, technical, and vendor-management responsibilities with strategic statistical thinking. The successful candidate will oversee regulatory submissions, define study designs, and mentor senior statisticians while collaborating with clinical

Qualifications

Ph.D. in Biostatistics (or related field) with extensive pharmaceutical industry experience.
Minimum 18 years in the pharma field with 10+ years in design, analysis and interpretation of clinical trials; 5+ years in people management.
Strong expertise in Bayesian and frequentist methods and modern adaptive trial designs.

Responsabilités

Ensure relevance and accuracy of state-of-the-art statistical methods in BioCryst studies.
Oversee statistical activities for regulatory submissions (NDA/BLAs).
Ensure data processing conforms to GCP.
Lead and manage junior biostatistics staff.
Coordinate CRO/vendor oversight for outsourced work.
Use SAS, EAST, R for analysis and sample size calculations.
Contribute to clinical development strategies and program design.
Present biostatistical topics to regulatory agencies.
Define metrics and monitor performance.
Prepare and review protocols, SAPs, data management plans, and regulatory documents.