CMC Biostatistician – Translational & Early Development (TED)

Position Overview

We are seeking a

CMC Biostatistician

to join the

Translational and Early Development (TED)

team within

Global Biostatistical Sciences (GBS) . The TED team supports

Vaccine Research & Development

and operates under the supervision of the TED Global Head. In this role, you will provide

statistical expertise across early-stage R&D , with a focus on

pre-clinical development, CMC (Chemistry, Manufacturing, and Controls), biological assays, and biomarker research . You will work closely with scientists and project managers, contributing to data-driven decision-making in a collaborative, fast-paced research environment. Key Responsibilities

Provide

statistical support

for early-stage vaccine R&D programs, including: Pre-clinical studies CMC-related activities Biological assay development Biomarker research and analysis Partner closely with

scientists, project managers, and cross-functional teams

to support study design, data analysis, and interpretation Collaborate with senior managers within the

TED team

to ensure alignment with scientific and development objectives Contribute to statistical strategies that support translational research and early development milestones Support high-quality, compliant statistical deliverables aligned with global R&D standards Qualifications & Experience

Degree in

Statistics, Biostatistics, Mathematics, or a related scientific field Experience providing statistical support in

R&D, pre-clinical research, CMC, bioassays, and/or biomarker studies Understanding of

vaccine development

or biologics development strongly preferred Ability to work collaboratively in a

cross-functional, scientific environment Strong communication skills with the ability to translate statistical concepts to non-statistical stakeholders

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