VP, Biostatistics & Regulatory Strategy

BioCryst Pharmaceuticals

Boston (MA)

On-site

USD 270,000 - 360,000

Full time

3 days ago

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Job summary

BioCryst Pharmaceuticals is seeking a Vice President of Biostatistics to lead the planning and delivery of statistical activities across clinical development. You will manage teams, oversee CRO partners, and ensure compliance with GCP and regulatory expectations.

The role requires extensive study design, regulatory strategy, and data-driven decision making. Key responsibilities include leading statistical strategy for NDA/BLA submissions, guiding innovative methodologies, and communicating

Qualifications

Ph.D. in Biostatistics (or related field) with extensive pharma industry experience.
10+ years in design, analysis and interpretation of clinical trials.
At least 5 years in people management and leadership.
NDA/BLA filing experience with contribution to multiple product approvals.
Expertise in Bayesian and frequentist statistics.

Responsibilities

Ensure relevance and accuracy of statistical methods in BioCryst-sponsored studies.
Oversee regulatory submissions and NDA/BLAs statistical activities.
Ensure data processing conformance to GCP and regulatory guidelines.
Lead and develop junior biostatistics staff and CRO/contract staff.
Communicate statistical concepts to technical/regulatory audiences.
Define and monitor performance metrics and SOCs for statistics.