Principal Biostatistician

Principal Biostatistician

Sanofi

Marcy-l'Étoile, France

About the job

As clinical Principal Biostatistician within our Vaccines Biostatistical Sciences team, you are the ultimate scientific owner of all statistical deliverables for your assigned study(ies) and project activities, bringing your passion for clinical trials design, statistical analysis, transforming insights into action and revolutionizing how we approach AI-driven evidence generation.

Job Summary

Assume responsibility for methodological and statistical aspects of one or several clinical studies, with general direction from Statistical Project Leader and/or Bios Franchise Lead. He/she will provide critical input on the design and analysis of our clinical trial data so that accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. He/she may be involved in supporting some project activities.

He/she will also be supporting the various changes linked to the development of new tools and processes.

Main responsibilities

• Act as the global biostatistics representative at clinical trial(s) level, contributing actively on clinical trial design (including sample size justification, estimand,…), owning the development of the Statistical Analysis Plan (SAP) and delivery of statistical analyses and key results interpretation with scientists;
• Propose, prepare, and perform exploratory and ad-hoc data analyses at study or cross-studies level to inform future trial objectives, internal decision making or submissions;
• Collaborate closely with cross-functional study team on the design (clinician), on safety monitoring (pharmacovigilance), on statistical programmers for the preparation and production of statistical reports and appendices at trial or asset level;
• Manage and oversee outsourced activities with external partners (CROs), ensuring quality, timely delivery and oversight documentation;
• Participate in project activities such as Clinical Development Plan development, decision-making meetings, integrated analyses, and dossier preparation, submission, and follow-up;
• Leverage AI & Machine Learning to augment biostatistics contribution – Leverage AI & Machine Learning in the analysis of clinical and real-world data. Explore and implement AI-powered tools (e.g., LLMs, code generation, automated QC) to accelerate and enhance analyses workflows—from data wrangling to output generation and validation;
• Contribute to process improvement and tool/automation development initiatives.

Required Qualifications

• Experience: Proven initial experience in pharmaceutical industry, preferably in clinical trials and data science. Proven track record in statistical analysis and methodology within a regulated environment;
• Technical Skills: Deep expertise in R programming (required), proficiency in Python and/or SAS (a plus). Strong knowledge basis in advanced statistical methods (e.g., Bayesian statistics, linear and non-linear modelling) and Machine Learning. AI knowledge is a plus. Familiarity with clinical trial data structures and regulatory requirements;
• Soft Skills: Excellent problem-solving and analytical mindset; Effective verbal and written communication skills. Strong ability of teamwork and adaptability in a fast-paced setting. Ability to influence across functions in a global environment and drive organizational change;
• Education: PhD in Biostatistics, Data Science, or related discipline or a Master's degree with equivalent experience. Preferred: coursework or projects involving healthcare, life sciences, or clinical research data;
• Digital Acumen: Ability to implement automation and digital transformation initiatives;
• Languages: Fluent in English (required).