Senior Statistical Programmer (SDTM)

Overview

Senior Statistical Programmer (SDTM) to provide technical expertise for clinical trial analysis and reporting as part of SDTM programming delivery.

What you'll do

• Act as an SDTM lead on clinical research studies.
• Develop SDTM Trial Design domains.
• Program and deliver complex SDTM datasets.
• Coordinate study and project start-up activities.
• Troubleshoot and debug moderate-complexity SAS macros.
• Review protocols and statistical analysis plans for SDTM mapping feedback.
• Support derived datasets, quality control, and mapping specification development.

What you'll need

• Degree in a relevant discipline or equivalent work experience.
• Relevant clinical trial industry experience.
• Proficiency in SAS and knowledge of programming and reporting processes.
• Knowledge of ICH-GCP and regulatory requirements, including 21 CFR Part 11.
• Experience supporting statistical programming activities for clinical study analysis and reporting.
• Excellent communication skills in written and oral English.
• Strong organizational skills to manage competing priorities.

Nice to have

• 5+ years of experience as a Statistical Programming Coordinator or study lead.
• Familiarity with CDISC standards, mapping specification development, and regulatory submission requirements.
• Experience developing standard macros or efficiency-enhancing programming solutions.
• Experience providing technical training, mentoring, or guidance.

Details

• Remote role.