Senior Statistical Programmer – Functional Service Provider

hace 1 semana


españa Kelly Science, Engineering, Technology & Telecom A tiempo completo

Senior Statistical Programmer – Functional Service Provider (FSP) Engagements Contract: 12 months with possible extension Are 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 Do Develop & 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 Are Experienced 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 breakthroughs Location Madrid, Community of Madrid, Spain Seniority level Mid‑Senior level Employment type Full‑time Job function Information Technology Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr



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