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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, under the Global Biostatistical Sciences (GBS) group. Responsible for methodological and statistical aspects of pre-clinical and/or non-clinical studies, providing input on design and analysis to support decision-making and regulatory expectations.

Responsibilities

  • Develop the digital mindset and data science of the 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 act as the referent for the platform.
  • Provide statistical input in the design of experiments for preclinical in vivo/in vitro studies, bioassay development, and analytical (CMC) work.
  • Contribute to the setup of studies to ensure data are adequately captured to address objectives.
  • Provide statistical support for experimental design, methodology, programming, and data analyses.
  • Prepare statistical analyses (planning, prioritization, forms, analyses), write memos/reports, and communicate conclusions to scientists.
  • Accountable for statistical operations: sample size calculations, randomization plan if applicable, and quality and delivery of statistical reports.
  • Accountable for statistical content: select methodologies, conduct risk assessment, interpret results, perform exploratory and ad-hoc analyses.
  • Coordinate with internal and external stakeholders (R&D compliance, Project Manager, CROs, etc.).
  • Under supervision, participate in project activities such as preclinical development plans, decision meetings, integrated analyses, dossier preparation, IND/CTD submissions, and publications.
  • Represent TED/GBS in internal initiatives and present statistical topics internally and externally.

Education

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

Experience

  • Experience in Life Sciences industries is a must.
  • Technical expertise in statistics, data science, and statistical modeling.

Soft Skills

  • Good communication skills.
  • Ability to work in a multi-cultural environment.
  • Ability to work in a team (team spirit, ease of communication).
  • Eager to learn and open-minded.
  • Good time management.
  • Autonomous.

Skills

  • R, JMP; ability to use SAS or Python is a plus.

Language

  • Effective English in verbal and written communication.