Senior Statisticien RWE

About this role

Join Excelya , where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role offers an exciting opportunity to join a Statistics team overseeing Real-World Evidence (RWE), non-interventional, and Secondary Use of Data (SUD) studies. You will provide statistical leadership, review study protocols and analysis plans, supervise external service providers, ensure the quality and timely delivery of statistical outputs, and work closely with cross-functional teams to support evidence generation and regulatory reporting Key Responsibilities : - Review study synopses and protocols, including sample size calculations, study design, endpoints, and statistical methodologies.

- Oversee statistical deliverables from external service providers, including Statistical Analysis Plans (SAPs), TFLs, and interim analyses. - Monitor study statistical milestones and track operational progress through vendor dashboards. - Ensure the timely delivery of statistical outputs and analysis datasets in compliance with Ipsen quality standards. - Perform quality control of statistical analyses, including SAS programming and programming validation activities.

- Review clinical study reports (CSRs) and all external communications related to study results and analyses. - Collaborate closely with cross-functional stakeholders, including Biometry, Clinical Operations, Medical teams, and external partners. - Ensure complete and accurate maintenance of study documentation, including accountability for eTMF completion. Requirements At Excelya, we encourage everyone to be bold, challenge themselves, and unlock their full potential.

We are looking for professionals who share our values and are eager to grow in a dynamic and stimulating environment. Education : Master’s degree in Statistics, Biostatistics, Epidemiology, or a related scientific discipline. Experience : Very strong experience in statistics and statistical programming within the pharmaceutical, biotech, or healthcare industry, including significant exposure to Real-World Evidence (RWE), non-interventional studies, and Secondary Use of Data (SUD) projects Skills : Hands-on experience with SAS programming and statistical validation.