Statistics Methodology Expert

Pierre Fabre is a global pharmaceutical company dedicated to the research, development, and commercialization of innovative drugs. Our Biometry Department is integral to our success, providing comprehensive support for all drug development initiatives, including Randomized Controlled Trials (RCTs) and Real World Evidence (RWE) studies. We are seeking a highly skilled and proactive Statistics Methodology Expert to join our Biometry Department located in Toulouse (Langlade, Oncopole). Working closely with statisticians, other R&D functions and external scientific networks, the Statistics Methodology Expert will strengthen methodological excellence, scientific quality and regulatory robustness across the portfolio, acting as a recognised authority in advanced statistical methodology within and beyond Pierre Fabre. Your role within a pioneering company in full expansion: Statistical Methodology and Scientific Support
• Provide expert methodological support for clinical trials and Real-World Evidence studies across all phases of drug development.
• Advise statisticians on advanced, innovative or complex statistical methods.
• Support statistical strategy and methodological discussions during interactions with health authorities.
• Promote consistent and scientifically robust statistical approaches across studies and therapeutic areas.
• Assess the statistical robustness of investigator-initiated interventional and non-interventional studies as part of relevant governance processes.
• Provide methodological input into the evaluation of external opportunities and due diligence activities, as needed.
• Influence development strategies and major portfolio decisions by ensuring that statistical considerations are integrated early into scientific and clinical decision-making. Methodological Innovation and Continuous Improvement
• Monitor advances in statistical science, regulatory thinking, technologies and industry practices.
• Define and champion Pierre Fabre’s methodological strategy in selected areas of advanced statistics, anticipating emerging scientific and regulatory expectations.
• Identify methodological areas for improvement and lead the evaluation and adoption of relevant approaches within Biometry.
• Translate new statistical methods into pragmatic guidance, tools, training and best practices.
• Contribute to the continuous improvement of statistical processes, quality, efficiency and reproducibility.
• Support the appropriate use of modern statistical computing environments, including R.
• Explore opportunities offered by automation, data science and AI to enhance statistical practice while maintaining scientific and regulatory rigour.
• Provide methodological oversight and expert review of key regulatory deliverables and submission packages. Capacity Building and Collaboration
• Develop and deliver training in statistical methodology for Biometry and other Pierre Fabre collaborators.
• Provide coaching and technical mentorship to statisticians on complex methodological topics.
• Promote the exchange of methodological knowledge, lessons learned and good practices across teams.
• Coordinate cross-functional methodological initiatives through influence and scientific leadership. External Engagement and Scientific Visibility
• Build and maintain a strong network of statistical experts in the pharmaceutical industry and academia.
• Represent Pierre Fabre in an influential capacity in international statistical working groups, professional societies and cross-industry initiatives.
• Shape external methodological thinking and regulatory science through working groups, scientific committees, consultation activities and interactions with health authorities.
• Participate in scientific committees for leading statistical and pharmaceutical conferences.
• Support and encourage statisticians in presenting their work through conference presentations and posters.
• Lead or contribute to publications in peer-reviewed statistical and scientific journals.
• Strengthen the visibility of Pierre Fabre’s Biometry Department and its methodological expertise. Your skills at the service of innovative projects:
• Advanced degree in Statistics, Biostatistics or a related field (Master's Degree or PhD). Established track record of methodological leadership and scientific influence within the pharmaceutical industry, regulatory science or academia.
• Proven ability to shape statistical strategy and defend complex methodological positions in regulatory or other high-impact scientific settings.
• Extensive experience in statistical methodology within the pharmaceutical industry or academia and supporting the design, analysis and interpretation of clinical trials.
• Experience working with cross-functional teams and contributing to interactions with regulatory or health-authorities.
• Experience in oncology or another therapeutic area relevant to Pierre Fabre would be an advantage. This position is compatible with teleworking up to 2 days a week according to company rules.

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...