> Markdown version of [/jobs/ext/1923943-lead-statistician-real-world-evidence-cdi-m-f-h](https://www.wearedevelopers.com/jobs/ext/1923943-lead-statistician-real-world-evidence-cdi-m-f-h). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Lead Statistician - Real World Evidence -CDI- M - F H - **Company:** Pierre Fabre - **Location:** Toulouse, France (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Coherent Remote File System (CRFS), SAS (Software), Clinical Data Management System - **Published:** August 5, 2026 - **Apply:** https://www.hellowork.com/fr-fr/emplois/82046034.html ## About the Role Advanced degree in Statistics (Master's Degree, ENSAI, ISUP, or PhD) or a related field. - A minimum of 6 years of experience in the pharmaceutical industry or a Contract Research Organization (CRO), with significant involvement in Real World Evidence studies from the outset. Mandatory Skills - Advanced statistical analysis skills - Proficiency in SAS software - Strong understanding of real-world evidence studies design and methodology - Familiarity with the specific methodologies and regulations associated with Real-World evidence studies. - Comprehensive understanding of both primary data collection and secondary data re-utilization in studies. - Familiarity with regulatory guidelines (ICH, EMA, FDA, NICE, ENcEPP) - Excellent written and verbal communication skills in English - Excellent communication and cooperation skills, with a rigorous and pragmatic approach. - Creativity, proactivity, rigor, autonomy, and collaborative spirit. - Strong ability to manage multiple studies simultaneously and maintain organization. Optional Skills - Experience with interventional studies - Knowledge of CDISC standards, Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position. ## Description Participate in the conception and design of Real-World Evidence studies, providing expert statistical support including study design, sample size determination, definition of study objectives and evaluation criteria, writing the statistical section of the protocol and development of the statistical analysis plan. - Act as the primary point of contact internally and externally for all statistical aspects of assigned projects and studies, attending project/study meetings and offering statistical guidance. - Contribute to the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals. - Draft and/or validate key study documents such as synopses, protocols, CRFs, data review plans, statistical analysis plans, statistical results, study reports and other study-level documents while ensuring timely deliverables. - Program and/or validate statistical analyses using SAS software. - Collaborate with project team and clinicians to interpret results, develop key messages, and contribute to scientific publications - Work with clinicians and medical writers to communicate findings to clinical and regulatory partners, prepare Response to Questions from regulatory agencies (EMA / FDA / PMDA / ...) and prepare summaries of results for regulatory documents - Contribute to the RWE strategy for the submission dossier to FDA and EMA. - Oversee the review of statistical documents within the team and supervise operational activities outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements. - Follow all industry standards, including ensuring that all statistical related documentation is included in the electronic Trial Master File (eTMF).. ## Related Videos - [Beyond Gut Feelings: The Rise of Data-Driven HR](https://www.wearedevelopers.com/videos/1326-beyond-gut-feelings-the-rise-of-data-driven-hr) - [AI in High-Stakes Industries: Lessons Learned](https://www.wearedevelopers.com/videos/100253-ai-in-high-stakes-industries-lessons-learned) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) - [Kettle and Pot or Peas in a Pod? A Debate on Open-Source and Proprietary Software](https://www.wearedevelopers.com/videos/1585-kettle-and-pot-or-peas-in-a-pod-a-debate-on-open-source-and-proprietary-software) ## Related Articles - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Best Companies to Work For in Paris: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/190-best-companies-to-work-for-in-paris-top-25-companies-in-2023) - [Average Salary in France](https://www.wearedevelopers.com/magazine/269-average-salary-in-france) - [Best Companies to Work For in France: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/189-best-companies-to-work-for-in-france-top-25-companies-in-2023) - [Data Analyst Salary in Switzerland](https://www.wearedevelopers.com/magazine/276-data-analyst-salary-in-switzerland) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk)