Principal Statistical Programmer
il y a 14 heures
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
-
Statistical Programmer
il y a 2 semaines
Paris, France Excelya Temps pleinJoin to apply for the Statistical Programmer role at Excelya 3 weeks ago Be among the first 25 applicants About The Role Excelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in...
-
Statistical Programmer II
il y a 1 semaine
Paris, Île-de-France ICON plc Temps pleinStatistical Programmer II (Data Scientist)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Statistical Programmer II/Data...
-
Statistical Programmer II
il y a 3 jours
Paris, Île-de-France ICON plc Temps pleinStatistical Programmer IIICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Statistical Programmer II/Data Scientist to join...
-
Statistical Programmer
il y a 2 semaines
Paris, France Excelya Temps pleinHybridOperations, Statistics & ProgrammingFull time Paris, Île-de-France, France OVERVIEW Description About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting...
-
Bio Statistical Programmer
il y a 1 jour
Paris, France Nanobiotix Temps pleinWe are looking for a self-started Biostatistical programmer to develop our clinical data platform and extensively game-changing nanomedicine products to help millions of patients around the globe. Since our inception, our team has been committed to researching and developing disruptive nanomedicine approaches that could revolutionise the way many cancers are...
-
Statistical Programmer – Clinical Data
il y a 2 semaines
Paris, France Excelya Temps pleinA leading health company is seeking a Statistical Programmer to join their team in Paris. This exciting role involves analyzing complex clinical data and collaborating with biostatisticians to ensure high-quality outcomes. The ideal candidate will have a Master's degree in a related field and advanced SAS skills. Join a dynamic group dedicated to advancing...
-
Principal Statistician
il y a 4 jours
Paris, France Ipsen Temps pleinOverview Principal Statistician – lead statistical strategy for global projects in Ipsen development portfolio. Location: Paris, France / Paddington, UK. Responsibilities Statistical adviser to global project teams, providing input for project development and contributing to statistical work for other projects as required. Collaborate with Early/Medical...
-
Principal Biostatistician
il y a 3 jours
Paris, Île-de-France IQVIA Temps pleinAs a Principal Biostatistician you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions.Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to...
-
Principal Statistician
il y a 4 jours
Paris, France Ipsen Group Temps pleinCookie Notice**Title:**Principal Statistician**Company:**Ipsen Innovation (SAS)**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the...
-
Principal Statistician
il y a 4 jours
Paris, Île-de-France Ipsen Temps pleinJob TitlePrincipal StatisticianDivision / FunctionR&D / Global Biometry / Biostats & ProgrammingManager's Job TitleDirector, BiostatisticsIpsen Job ProfileClinical Science > BiostatisticsLocation:Paris, FR/Paddington, UKWHAT - Summary & Purpose Of The PositionThe Principal Statistician is the lead for the statistical strategy of one or more projects/studies...