VP, Biostatistics

BioCryst Pharmaceuticals, Inc.

. Ensure relevance, adequacy and accuracy of state-of-the-art statistical methods in BioCryst-sponsored clinical development activities and selected nonclinical studies .

Posted 9/25/2026full-timeRemote • Massachusetts • United StatesLeadWebsite

About the role

Key responsibilities & impact

Ensure relevance, adequacy and accuracy of state-of-the-art statistical methods in BioCryst-sponsored clinical development activities and selected nonclinical studies
Oversee statistical activities for regulatory submissions, including NDA/BLAs
Ensure clinical data processing conforms to regulatory guidelines and Good Clinical Practice
Contribute to clinical development strategies, including development program and study design
Lead and manage junior biostatistics staff
Select, direct and supervise CRO and contract staff performing outsourced operational activities
Use SAS, EAST and R for ad hoc data analyses and sample-size work
Participate in clinical development and product management teams
Represent the company on biostatistical topics at FDA and other regulatory agency meetings
Define, create and implement organization-wide processes focused on efficiency and productivity
Define, monitor and evaluate relevant performance metrics
Author and review critical product-development documents, including protocols, statistical analysis plans, data management plans, regulatory briefing documents, NDAs, MAAs, regulatory responses, abstracts and manuscripts
Ensure accuracy of clinical-trial data in public corporate communications and monitor their quality-audit process
Communicate technical concepts rigorously to technical, regulatory and nontechnical audiences

Requirements

What you’ll need

Ph.D. in Biostatistics or related field with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials, or an equivalent combination of education and experience
At least 5 years of people management and leadership experience
Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making
NDA/BLA filing experience and key contributor experience to multiple successful product approvals
Proven expertise with biostatistics disciplines, practices and procedures, including development and accountability for relevant quality management systems
Experience with Data Monitoring Committees and/or study steering committees
Hands-on approach, including performing analyses when necessary
Excellent written and verbal communication skills
Ability to work well in a collegial environment and willingness to challenge the status quo
Experience with global regulatory agencies
Formal expertise and experience in Bayesian and frequentist statistics
Ability to embrace change within a high-risk environment

Benefits

Comp & perks

Equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics
Compliance with all federal, state and local law