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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Lead Statistical Programmer- CDI -M - F H - **Company:** Pierre Fabre - **Location:** Toulouse, France - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Data Analysis, Computer Programming, R (Programming Language), Python (Programming Language), SAS (Software), SQL Databases, Data Processing, Clinical Data Management System, Data Management, Programming Languages - **Published:** August 5, 2026 - **Apply:** https://www.hellowork.com/fr-fr/emplois/82046093.html ## About the Role Your skills at the service of innovative projects: - 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 hands-on experience in RCTs and RWE studies. - Programming in CDISC (SDTM & ADaM) and writing associated documentation (Define, ADRG...) Mandatory Skills - Proficiency in SAS and R programming languages - Extensive experience in Randomized Controlled Trials (RCTs) - Strong knowledge in CDISC (SDTM & ADaM) and associated documents (Define, ADRG, ...) - Strong knowledge of international scientific and regulatory recommendations (e.g., ICH, EMA, FDA) - Ability to collaborate effectively with statisticians, data managers, and other stakeholders - 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 other statistical programming languages (e.g., Python, SQL) - Knowledge of Real-World Evidence (RWE) studies - Experience in EMA, FDA or PMDA submissions - Experience in oncology clinical trials Application Process Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position. ## Description We are currently seeking a highly skilled and experienced Lead Statistical Programmer to join our Biometry Department, part of the Data Science & Biometry Department based in Toulouse (31, Langlade, Oncopole) or Boulogne (92). This position requires a strong expertise in the application of programming within the context of randomized controlled trials (RCTs). The successful candidate will be agile and adaptable, capable of working in a matrix-organized environment where collaboration across Data Management, Programming, and Statistics is essential. Whilst an excellent track record in Randomized Controlled Trials is a must, the successful candidate will also contribute to Real Worl Evidence (RWE) studies., Participate in the design and execution of RCTs and RWE studies, ensuring high-quality programming support. - Develop and validate programs for data analysis, reporting, and visualization in accordance with regulatory guidelines and standards (e.g., ICH, EMA, FDA, PMDA). - Collaborate with statisticians, data managers, and other stakeholders to ensure accurate and efficient data processing and analysis. - Assist in the selection and evaluation of subcontractors, establishing clear requirements and evaluating proposals. - Contribute to the preparation of regulatory documents and scientific publications by providing programming support and expertise. - Follow all industry standards, including ensuring that all biometry-related documentation is included in the electronic Trial Master File (eTMF). 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