Sr. Non-Clinical Biostatistician

Role Summary

The Sr. Non-Clinical Biostatistician supports Vaccine R&D within the TED (Translational and Early Development) team, providing statistical input for pre-clinical and non-clinical studies, bioassay, biomarker research, and CMC activities. The role involves leading statistical projects with minimal supervision, collaborating with scientists and project managers, and ensuring regulatory compliance. Responsibilities include study design, data analysis, and clear communication of statistical conclusions to stakeholders.

Responsibilities

• Develop the digital mindset and data science capabilities of clients under responsibility (communications, training, etc.).
• Support the digital evolution of the site within its scope of activity.
• Perform technology watch on data science topics and serve as the platform referent.
• Provide statistical input in experimental design for in vivo/in vitro preclinical studies and/or research, plus clinical and analytical (CMC) bioassay development.
• Contribute to study setup to ensure data are adequately captured to address objectives.
• Provide statistical support for experimental design, methodology, programming, and data analyses.
• Produce statistical analyses (planning, prioritization, forms, analysis reports), write memos/reports, and explain statistical conclusions to scientists.
• Ensure accountability for statistical operations, including sample size calculations, randomization plan compliance, and delivery of statistical methodology and reports.
• Oversee statistical content: select methodologies, assess risk, interpret results, perform exploratory/ad-hoc analyses when applicable.
• Coordinate with internal and external stakeholders (R&D compliance, Project Manager, CROs, etc.).
• Under supervision of TED team senior manager or Research lead, participate in preclinical development planning, decision meetings, analyses, dossier preparation, IND/CTD submission, and publications follow-up.
• Represent TED and GBS in internal initiatives; present topics related to statistical activity.

Qualifications

• Education
• Required: Master’s degree in Statistics with 4 years of industry experience OR PhD in Statistics/Biostatistics with internship in life sciences.
• Experience
• Required: Experience in Life Sciences industries; technical expertise in statistics, data science, and statistical modeling.
• Soft Skills
• Good communication skills; ability to work in a multi-cultural environment; teamwork; eagerness to learn; good time management; autonomous.
• Statistical Tools
• R, JMP; knowledge of SAS or Python is a plus.
• Language
• Effective English in verbal and written communication.