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Sr. Non-Clinical Biostatistician

Sanofi
On-site
Waltham, MA
Clinical Research and Development

Role Summary

Sr. Non-Clinical Biostatistician supporting Vaccine R&D within the Translational and Early Development (TED) team. Provides statistical design, analysis, and interpretation for preclinical and non-clinical studies, collaborating with scientists and project managers to ensure regulatory-compliant decisions. Oversees statistical operations and supports data-driven decision making under supervision of senior TED leadership.

Responsibilities

  • Lead statistician for preclinical/non-clinical statistical requests and related matters with minimal supervision.
  • Develop digital mindset and data science capabilities for clients; support digital evolution of the site.
  • Perform technology watch on data science topics and act as referent for data platforms.
  • Provide statistical input in experimental design for in vivo/in vitro preclinical studies, bioassay development (clinical, analytical, CMC).
  • Contribute to study setup to ensure data are captured to address objectives.
  • Provide statistical support for experimental design, methodology, programming, and data analyses; prepare analyses and reports.
  • Oversee statistical operations including sample size calculations, randomization plan compliance, and delivery of statistical reports.
  • Ensure statistical content quality: select methodologies, assess risk, interpret results, perform exploratory/ad-hoc analyses.
  • Collaborate with internal and external stakeholders (R&D compliance, project managers, CROs, etc.).
  • Participate in project activities under supervision, including development plans, decision meetings, integrated analyses, dossier preparation, IND/CTD submissions, and publications.
  • Representative in TED and GBS initiatives; present statistical topics internally and externally.

Qualifications

  • Master's degree in Statistics with 4 years industry experience OR PhD in Statistics/Biostatistics with internship in life science.
  • Experience in Life Sciences industries is a must.
  • Technical expertise in statistics, data science, statistical modelling, etc.

Skills

  • Good communication skills; ability to work in a multi-cultural environment; team-oriented; autonomous.
  • Strong time management and willingness to learn.
  • Statistical Tools: R, JMP; familiarity with SAS or Python is a plus.
  • Language: Effective English in verbal and written communication.

Education

  • Master's degree in Statistics with 4 years industry experience OR PhD in Statistics/Biostatistics with internship in life science.