Senior Statistical Programmer - Functional Service Provider (FSP) Engagements

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. You'll collaborate with leading biostatisticians, CRO partners, and project teams, using your technical expertise to ensure accuracy, compliance, and excellence in every deliverable.

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!

• Work with Industry Standards: Apply your knowledge of CDISC SDTM and ADaM mapping, including using 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: Partner closely with biostatisticians and cross-functional teams to align analyses and troubleshoot data issues for smooth study progress.

• Mentor & Guide: Share your expertise with junior programmers and help foster a culture of learning and best practices.

• Handle Complex Outputs: Tackling dynamic reporting, ad-hoc analyses, and advanced statistical logic will be part of your everyday.

• 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.

Do you have a Master's degree?, * 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!