Société : Servier Catégorie : Offre emploi CDI Activité : Santé / Médical / Social Filiere : Fonctions Médicales & Sociales Lieu : Essonne (Île-de-France)
Mission
As Biostatistics Project Lead within the Servier Group, you join a committed international team responsible for the methodological and statistical approaches implemented in our clinical studies and as part of the associated development plans.You coordinate the biostatistical activities of your assigned projects and studies, while ensuring state-of-the-art methodologies and deliverables, in compliance with internal and regulatory guidelines and policies.Missions & Activities Provide statistical support for clinical studies, including Representing the Biostats group on clinical study teams, Providing input on the development of study protocols (choice and implementation of design, sample size estimation, simulation to assess trial operating characteristics, statistical analysis strategy), Writing statistical analysis plans with programming specifications, and other clinical documents, Managing the development of statistical outputs and documents with programming team, Ensuring the interpretation of statistical results in clinical documents and providing input on publications. Responsible for interacting with regulatory authorities on clinical trial statistical issues. Participate in the preparation of regulatory filing documents and responses to questions from regulatory agencies. Provide oversight of statistical tasks for studies that are outsourced to CRO partners. Responsible for the discussion and implementation of rigorous, informative and when appropriate, innovative study designs, statistical models, and analysis methodologies that optimally address the research objectives. Develop, implement or advise on appropriate new statistical methodologies and keep abreast of current issues and developments in statistical theory and applications. Contribute to the development and optimization of the development strategy of projects in the early phase. Lead or contribute to departmental/cross-functional process improvement initiatives and working groups on methodological issues. Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOP. Contribute to the internal and external visibility of the department and promote the development of internal scientific knowledge. Profiles & Skills Master or Doctoral degree or equivalents in Biostatistics, Statistics or closely related fileds. You demonstrate: Extensive experience as clinical statistician supporting clincial trials Strong orientation to technical / methodological innovations Mastery of regulatory guidelines (FDA, EMEA, ICH) Broad knowledge of advanced statistical concepts and techniques in clincial trials Capability to provide strategic inputs in broader contexts. SAS and R expertise and working knowledge of CDISC standards You also show: Strong interpersonal and communication capacities Team leadership Organization skills Capability to work on several projects simultaneously Detail & results orientation Perfect ease working with distant management and in English Positions offered is based at our new international R&D headquarters, at the heart of the Paris Saclay cluster.CLIQUER ICI POUR POSTULER
