Lead Statistical Programmer- CDI -M/F

• 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).

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., 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

We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation, very attractive CE...

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies. Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care. Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. In 2019, Ecocert Environment assessed the Group's corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the "Excellence" level. Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.