Senior Statistical Programmer – Functional Service Provider

hace 1 semana


Madrid, España Kelly Science, Engineering, Technology & Telecom A tiempo completo

Senior Statistical Programmer – Functional Service Provider (FSP) EngagementsContract: 12 months with possible extensionAre you passionate about transforming clinical data into meaningful insights? Join our team as a Senior Statistical Programmer, where you’ll take an active role in delivering programming solutions that drive successful clinical studies and regulatory submissions.What You’ll DoDevelop & Validate Clinical Programs: Create and maintain robust SAS programs to generate high-quality datasets, tables, listings, and figures (TLFs) for clinical studies, always meeting timelines.Ensure Data Quality: Validate and QC all datasets and outputs to guarantee compliance with regulatory standards—accuracy, consistency, and traceability are key.Apply Industry Standards: Use CDISC SDTM and ADaM mapping, including Pinnacle 21 validation, for regulatory submissions.Support Study Documentation: Review protocols, CRFs, SAPs, and mapping specifications to fully understand study objectives and analysis plans.Collaborate with Biostatisticians: Partner closely with biostatisticians and cross‑functional teams to align analyses and troubleshoot data issues for smooth study progress.Mentor & Guide Junior Programmers: Share expertise with junior programmers and foster a culture of learning and best practices.Handle Complex Outputs: Tackle dynamic reporting, ad‑hoc analyses, and advanced statistical logic as part of everyday work.Drive Submission Readiness: Prepare and review key submission documents such as define.xml, annotated CRFs, and reviewer guides for regulatory compliance.Deliver Excellence Under Pressure: Manage multiple tasks, prioritize effectively, and consistently deliver high‑quality work—even in fast‑paced environments.Promote Standardization & Improvement: Champion process enhancements, standard procedures, and the use of the latest tools in programming, automation, and data visualization.Who You AreExperienced Programmer: Master’s degree (5+ years) or Bachelor’s (7+ years) in Statistics, Computer Science, or related field, with strong FSP engagement experience.Clinical Data Expert: Skilled in statistical programming, data manipulation, reporting, and analysis for clinical trials.CDISC Standards Champion: Solid knowledge of SDTM and ADaM, plus experience with Pinnacle 21, define.xml tools, and eCTD submissions.Problem‑Solver: Organized, proactive, and able to manage multiple priorities independently.Team Player: Excellent communicator who thrives in collaborative environments, but also excels working autonomously.Innovator: Exposure to programming automation, visualization, or metadata‑driven tools such as R, Python, or Spotfire is a plus.Ready to make a real difference in clinical research? Apply now and help us deliver the data that powers tomorrow’s breakthroughsLocationMadrid, Community of Madrid, SpainSeniority levelMid‑Senior levelEmployment typeFull‑timeJob functionInformation TechnologyIndustriesPharmaceutical Manufacturing and Biotechnology Research#J-18808-Ljbffr



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