Pierre Fabre Laboratories

Role Description Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne. This position can be filled remotely. This position requires a strong expertise in the application of statistics within the context of Real-World Evidence studies. 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 RWE is a must, the successful candidate will also contribute to clinical trials, including randomized controlled trials (RCTs). The Biometry Department at Pierre Fabre supports all drugs being developed by the company. The department encompasses Data Management, Programming, and Statistics, working cohesively to ensure the successful completion of both Randomized Controlled trials and Real-World evidence studies. Your role within a pioneering company in full expansion: - 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). Qualifications - 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. Requirements - 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. Benefits - Attractive remuneration/benefits package. - Incentives and 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. - CE (Comité d'Entreprise) benefits. Terms of Employment - Full-time position. - Work location: full remotely or hybrid with 2 days per week from home. Application Process Interested candidates should submit their resume and a cover letter detailing their experience and qualifications for this position. The hiring manager is Florence Carrère, Biometry Manager. The Head of the Biometry Department is Guillaume Desachy. We look forward to welcoming a new member to our dedicated and innovative team at Pierre Fabre.