Executive Director, Biometrics

BioCryst Pharmaceuticals, Inc.

. Lead the conduct and analysis of BioCryst-sponsored clinical studies from Phase I to Phase IV and selected non-clinical studies .

Posted 10/2/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Biostatistics and Clinical Trial Design, with a strong focus on Regulatory Compliance and Quality Management Systems. Proven ability to lead cross-functional teams and communicate complex statistical concepts to diverse audiences.

Highest-signal resume keywords

Ph.D. In BiostatisticsSAS ProgrammingClinical Trial DesignNDA Filing ExperienceBiostatistics Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

BiostatisticsStatistical AnalysisClinical Data ManagementBayesian StatisticsFrequentist StatisticsQuality Management SystemsPerformance Metrics EvaluationStatistical ProgrammingRegulatory GuidelinesClinical Development Process

Soft Skills

Leadership SkillsInterpersonal SkillsExcellent Communication SkillsAbility To PrioritizeCollegial Collaboration

Industry Keywords

Good Clinical PracticeFDA MeetingsData Monitoring CommitteesStudy Steering CommitteesEuropean Regulatory AgenciesJapanese Regulatory Agencies

About the role

Key responsibilities & impact

Lead the conduct and analysis of BioCryst-sponsored clinical studies from Phase I to Phase IV and selected non-clinical studies
Provide Biometrics support for clinical studies, selected non-clinical studies, and Medical Affairs
Ensure relevance and adequacy of statistical methods and conformance to regulatory guidelines and Good Clinical Practice
Contribute to clinical development strategies, development programs, and study design
Oversee CRO and contract staff performing outsourced operational activities
Review and approve contracts, work orders, and invoices within delegated authority
Act as project statistician for an individual project
Participate in FDA and other regulatory agency meetings as the company’s biostatistical spokesperson
Define, create, and implement organization-wide processes focused on efficiency and productivity
Define, monitor, and evaluate relevant performance metrics
Author and review statistical and biometrics sections of protocols, statistical analysis plans, data management plans, regulatory documents, NDAs, MAAs, regulatory responses, abstracts, and manuscripts
Ensure accuracy of clinical trial data in public corporate communications, including press releases, presentations, SEC filings, abstracts, and manuscripts
Monitor the quality audit process for public clinical trial communications
Communicate technical concepts to technical, regulatory, and broader nontechnical audiences
Identify, evaluate, and implement new biostatistics and programming processes and technologies
Develop and align outsourcing strategy with Clinical Development goals
Perform additional duties as assigned

Requirements

What you’ll need

Ph.D. in Biostatistics or related field with at least 12 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
Deep understanding of SAS programming sufficient to provide oversight of statistical programming and ability to program as needed
Strong leadership and interpersonal skills
NDA filing experience as a key contributor to one or more successful product approvals
Proven expertise in biostatistics, programming, and clinical data management, including development and accountability for relevant quality management systems
Demonstrated knowledge of the clinical development process and relevant regulatory guidelines and requirements
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 challenge the status quo
Experience with European and Japanese regulatory agencies
Formal expertise and experience in Bayesian and frequentist statistics
Flexible scheduling and ability to travel internationally
Responsiveness and ability to prioritize effectively

Benefits

Comp & perks

Equal employment opportunity protections
Protected Veterans/Individuals with Disabilities status protections
Flexible scheduling
Opportunity to work on innovative first-in-class or best-in-class therapeutics
International travel opportunities