Principal Statistical Programmer

il y a 14 heures


Paris, France Ipsen Temps plein

Position SummaryPrincipal Statistical Programmer – Global Biometry. Participate in production/QC programming, project coordination, CRO management, and oversight of vendor programming across Ipsen rare disease studies. Ensure clinical datasets meet regulatory standards for INDs, NDAs/MAAs, and submit CLiR, safety updates, and integrated summaries.ResponsibilitiesEnsure efficiency and quality of biometry deliverables; validate all clinical datasets for regulatory submissions.Lead Statistical Programming activities: analyze, integrate, report clinical trial data using SAS; produce tables, listings, figures for Clinical Study Reports, annual IND safety updates, and Integrated summaries (ISS/ISE).Create and QC CDISC SDTM and ADaM files, SAS export files, and Define.xml for electronic submissions from non‑standard data sources.Validate graphs, tables, figures; collaborate with Statisticians, Programmers, and clinical team to perform ad hoc analyses and generate outputs per requirements.Review CRFs, annotated CRFs, Data Management Plans, and edit check specifications; participate in operations meetings and address issues influencing statistical programming and data management.Work with CRO statisticians and programmers; review and QC their deliverables; manage multiple simultaneous projects and deadlines with shifting priorities in a fast‑paced environment.Knowledge & AbilitiesEducation: Bachelor’s degree (or foreign equivalent) in Biotechnology, Statistics, Mathematics, or related scientific discipline.Experience5+ years of experience in statistical programming or a related occupation.LanguagesEnglish.Key Technical CompetenciesProficient SAS programming language and SAS/BASE procedures.Experience with regulatory requirements (FDA, ICH) and NDA/IND submissions.Expertise in extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures, SAS/MACRO, SQL, and SAS/GRAPH.Understanding of clinical trials – how programming deliverables fit into the process and data structure (tall and wide).Experience developing and QCing SDTM, ADaM, Define XML, and Reviewer’s Guide per CDISC specifications.Ability to draft programming requirements from SAP and propose technical coding solutions.Employment TypeFull‑time.Job FunctionResearch, Analyst, and Information Technology.ReferralsReferrals increase your chances of interviewing at Ipsen by 2x. #J-18808-Ljbffr


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