Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. 

JOB PURPOSE

Lead one or several early  phase studies in Oncology and/or translational Medicine related activities (e.g. biomarkers methodology and analyses), under minimum supervision of statistical project leader and/or team leader.

KEY ACCOUNTABILITIES / RESPONSIBILITIES

Provide support and leadership to the clinical trial study and/or project team on all relevant statistical matters

• 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 assigned statistical deliverables related to one study or specific domain (e.g. biomarkers): 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 (TLGs and in-text tables)
• 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 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. This can include specific biomarker analyses ( e.g. pre-processing and normalization of biomarker data, high dimension analyses)
• Review submission documents, such as IND, NDA, BLA, CTE or cTD to insure statistical validity and accuracy
• Contribute to define and review the specific deliverables related to Transparency and Disclosure
• Provide technical guidance to junior staff
• Plan and track study/project activities and timelines
• Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation
• Represent statistics to participate in scientific or technology working groups or cross function initiatives
• Contribute to operation process optimization and provide inputs to statistics standards

PROFILE / REQUIREMENTS 

• PhD/MS in statistics or related discipline with at least 3 years of pharmaceutical experience
• Good knowledge of pharmaceutical clinical development, together with Late Phase and/or early Phase experience
• General biomarker knowledge in omics data and bioinformatics is preferred
• Broad knowledge and good understanding of advanced statistical concepts and techniques
• Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (R, …)
• Demonstrated strong interpersonal and communication skills

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.