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Associate Statistical Project Leader

Sanofi -
Barcelona, Barcelona provincia

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Detalles del empleo

Cualificaciones

Investigación clínica
Doctorado
SAS
R
Inglés
Investigación
Máster

Descripción completa del empleo

Associate Statistical Project Leader

Location: Barcelona, Spain

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

Join our Biostatistics Immunology & Inflammation (I&I) as Associate Statistical Project Leader and you will lead several I&I phase 2 or 3 studies under minimum supervision of statistical project leader and/or team leader. You’ll have opportunities to develop innovative statistical solutions to support critical trial decision-making and advance treatment across all phases of drug development. Within our department of Evidence Generation and Decision Science, you’ll be supported by a Biostatistics group that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses.
Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices.
Effectively utilize external groups, e.g. CROs or data monitoring committees (DMC).
Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan.
Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties.
Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity and scientific validity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.

About You

PhD in Statistics, or related quantitative discipline strongly preferred and will be given preference in candidate selection due to the advanced statistical methodology required for this role. MS in Statistics or related discipline required as minimum qualification.
A minimum of 3 years of pharmaceutical experience in clinical development, such as in Biotech, Pharma, Clinical Research Organizations (CROs), health authorities, or academic clinical research centers.
Highly preferred: Experience with phase 2/3 clinical trials and statistical modeling methodologies for late-stage development.
Broad knowledge and good understanding of advanced statistical concepts and techniques; being able to do advanced statistical analyses using SAS or R.
Proficient in written and spoken English

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