Senior Director, Biostatistics

🕒 Julho 24

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Sabin Vaccine Institute

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 1993

🏥 Saúde

💼 Consultoria

🍽️ Alimentos e Bebidas

💰 $35.000.000 Grant em 2023-01

Healthcare • Consulting • Food & Beverage

O Instituto de Vacinas Sabin se dedica a melhorar a saúde global, garantindo o acesso a vacinas que salvam vidas. O instituto foca em pesquisa e desenvolvimento de novas vacinas para algumas das doenças mais urgentes do mundo, incluindo cólera, HPV, malária, Marburg e Ebola. Através de programas e parcerias inovadoras, a Sabin busca melhorar as capacidades de imunização e a aceitação de vacinas dentro das comunidades, esforçando-se para tornar a vacinação acessível a todos, especialmente às populações vulneráveis.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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