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Senior Director, Biostatistics
Sabin Vaccine InstituteSenior Director of Biostatistics leading statistical activities supporting late-stage vaccine development programs. Ensuring statistical rigor and providing strategic input for Phase 2/3 clinical trials through team collaboration.
Tech Stack
Tools & technologiesPython
About the role
Key responsibilities & impact- Provide strategic leadership for statistical activities supporting late-stage vaccine development programs
- Ensure statistical rigor across clinical development, translational sciences, and CMC
- Provide strategic input to senior leadership on statistical implications of development strategies
- Lead statistical strategy for Phase 2/3 clinical trials
- Oversee statistical deliverables from CROs and external partners
- Partner with clinical and translational teams to support immunobridging models
- Guide statistical design and analysis of pivotal nonclinical studies
- Manage relationships with external vendors, key opinion leaders, and regulatory agencies
- Mentor and develop internal statisticians and other team members
Requirements
What you’ll need- Minimum of a graduate degree in Biostatistics, Statistics, or related field; doctoral degree strongly preferred
- 14+ years of biostatistics experience in pharma/biotech, with substantial leadership in late-phase clinical development
- Expertise in clinical trial design, regulatory submissions, and statistical modeling in vaccines or infectious diseases.
- Experience with immunobridging, logistical regression methods, and Bayesian or frequentist modeling
- Working knowledge of CMC statistics, assay validation, and nonclinical study design.
- Proficiency in statistical programming (e.g., SAS, R, Python); experience with CDISC standards is a plus
- Proven leadership, communication, and cross-functional collaboration skills
Benefits
Comp & perks- medical, dental, and vision coverage
- flexible spending accounts
- flexible vacation and sick leave
- employer-paid life and disability insurance
- 11 federal holidays
- end-of-year winter break
- employer-matching 401(k) plan
ATS Keywords
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Hard Skills & Tools
biostatisticsclinical trial designregulatory submissionsstatistical modelingimmunobridginglogistical regressionBayesian modelingfrequentist modelingCMC statisticsassay validation
Soft Skills
leadershipcommunicationcross-functional collaborationmentoring
Certifications
graduate degree in Biostatisticsgraduate degree in Statisticsdoctoral degree in related field