Late Phase Statistician

Late Phase Statistician
- Clinical DevelopmentNous utilisons des cookies pour vous offrir une meilleure personnalisation et des fonctionnalités avancées lorsque vous utilisez notre site. Pour poursuivre et faciliter votre navigation sur le site, vous pouvez directement accepter l'utilisation des cookies. Sinon, vous pouvez personnaliser l'utilisation des cookies. Pour en savoir plus sur le traitement de données personnelles, consultez notre politique de confidentialité en cliquant ci-dessous : Politique de confidentialité.# Carrières## Late Phase Statistician
- Clinical DevelopmentPostuler: Haute Garonne (31): Hauts-de-Seine (92): Temps plein: Offre publiée hier: JR114437# 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 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. We are seeking a highly skilled and experienced Senior Statistician (6+ years of experience in a similar position) to join our Biometry Department and provide statistical leadership for late-stage clinical development programs, primarily phase IIb and phase III randomized controlled trials and activities supporting regulatory submissions. The successful candidate will interact with Health Authorities and will play a central role in the design, execution, analysis, interpretation, and reporting of confirmatory clinical trials intended to provide robust evidence of efficacy and safety. The position requires strong expertise in estimands, confirmatory testing strategies, missing data, sensitivity analyses, multiplicity control, safety and efficacy integrated analyses, and regulatory submissions. 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. Your role within a pioneering company in full expansion:

Key Responsibilities
* Participate in the conception and design of phase IIb and phase III randomized controlled trials, providing expert statistical support for study design, sample size determination, randomization, endpoint selection, estimand definition, and confirmatory testing strategies.
* Lead the statistical definition and justification of primary and key secondary endpoints, analysis populations, intercurrent event strategies, missing data approaches, sensitivity analyses, and multiplicity adjustments.* Contribute to the design and statistical oversight of interim analyses, Independent Data Monitoring Committees, adaptive confirmatory designs, and event-driven analyses, where applicable.
* 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.
* 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 and/or R
* Collaborate with clinicians to interpret results, develop key messages, and communicate findings to clinical and regulatory partners.
* Contribute to the development of submission strategies and statistical content for regulatory dossiers submitted to agencies such as EMA, FDA, and PMDA
* Coordinate the production of integrated summaries and pooled analyses of efficacy and safety, ensuring consistency across studies, endpoints, and populations
* Support regulatory inspections, submission readiness activities, and the traceability of statistical decisions and deliverables
* Work with clinicians and medica