Associate Statistical Project Leader

Associate Statistical Project Leader

Sanofi

Barcelona, Spain

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.

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.