RWE Strategy Lead

## RWE Strategy Lead
- H/FPostuler: Hauts-de-Seine (92): Haute Garonne (31): Temps plein: Offre publiée aujourd'hui: JR114187# Qui sommes-nous ?Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle. Vous devenez acteur du \"We Care Movement\", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du \"We Care Movement\".# Votre missionThe Integrated RWE Strategy department, part of the Medical & Patient Consumer Division, is seeking a Real World Evidence Strategy Lead, based at its Boulogne or Toulouse site. You will be responsible for the scientific strategy of real-world evidence generation projects, ensuring their alignment with medical, regulatory and strategic objectives. You will lead the methodological design of RWE studies and be accountable for the rigorous and critical interpretation of data, in order to deliver robust conclusions and clear, actionable messages. Your role within the Integrated RWE Strategy department* Define and drive the scientific strategy for real-world evidence (RWE) generation for assigned products, indications or programs, in alignment with medical, regulatory and public health priorities. Contribute, together with R&D, Medical Affairs, HEOR, Regulatory, Biometry and other departments, to the Integrated Evidence Generation Plan (IEGP), ensuring the consistency and strategic value of the evidence generated.
* Challenge and refine the scientific, medical and regulatory objectives of projects, and translate decision-making questions into relevant research questions.
* Lead the methodological design of RWE studies, from the formulation of the research question through to the final design: population, exposure/intervention, comparator, endpoints, study period, strategy for controlling bias and confounding, sensitivity analyses and statistical approaches, in close collaboration with biostatisticians.
* Identify and select the most relevant and usable data sources for each research question. Conduct or oversee Fit-for-Purpose Assessments (FFPA) to document, in a structured manner, the suitability of one or more data sources for a given research question.
* Develop in-depth expertise in the assigned diseases and indications, standards of care, available data sources, RWE methods and regulatory expectations, in order to justify and defend methodological choices throughout study development.
* Be accountable for the scientific rigour of protocols and oversee the development of statistical analysis plans. Anticipate biases, confounding factors, missing data and methodological limitations, and define appropriate mitigation strategies.
* Critically interpret the results of complex analyses and place them in their clinical, methodological and regulatory context. Turn results into scientifically robust conclusions and recommendations that support decision-making. Disseminate these results through reports, abstracts, posters, publications and other scientific materials.
* Provide scientific support to operational teams and external partners to ensure implementation that is faithful to the protocol, the scientific objectives and the methodological requirements of the study.
* Review and scientifically validate RWE studies initiated by affiliates and contribute to building team capabilities by promoting good practices in pharmacoepidemiology and RWE.# Qui êtes-vous ?
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Education:
Master's degree or PhD in epidemiology, pharmacoepidemiology or public health, or medical doctor/pharmacist with significant experience in designing observational studies.
* Strong analytical and methodological skills, with a demonstrated ability to design studies, apply advanced pharmaco-epidemiological approaches, and interpret and communicate complex analyses.
* Proven experience as Lead Author of observational study protocols: direct and full responsibility for the methodological design of the study and the development of the protocol. Experience focused primarily on project management or study operations does not meet the requirements of the position.
* Demonstrated experience in the design and/o