Senior Director, Biostatistics

🕒 July 24

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Sabin Vaccine Institute

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 $35M Grant on 2023-01

Healthcare • Consulting • Food & Beverage

Sabin Vaccine Institute is dedicated to improving global health by ensuring access to life-saving vaccines. The institute focuses on research and development of new vaccines for some of the world’s most pressing diseases, including cholera, HPV, malaria, Marburg, and Ebola. Through innovative programs and partnerships, Sabin aims to enhance immunization capacities and vaccine acceptance within communities, ultimately striving to make vaccination accessible to all, especially vulnerable populations.

📋 Description

• Provide strategic leadership for statistical activities supporting late-stage vaccine development programs • Ensure statistical rigor across clinical development, translational sciences, and CMC • Lead statistical strategy for Phase 2/3 clinical trials, including study design, SAP development, and data interpretation • 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 • Provide statistical expertise in process development, analytical validation, and shelf-life modeling • Manage relationships with external vendors, key opinion leaders, and regulatory agencies • Mentor and develop internal statisticians and team members

🎯 Requirements

• Minimum of a graduate degree in Biostatistics, Statistics, or a 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

• 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