SDTM, Clinical SAS Programmer

The SDTM, Clinical SAS Programmer is responsible for developing, transforming, reviewing, and validating clinical trial data using SAS programming and CDISC standards. The role supports clinical study teams and biostatisticians by creating high-quality SDTM datasets, programming utilities, and regulatory submission deliverables while ensuring compliance with FDA, ICH, and CDISC requirements.

• Looking for SDTM experts having in-depth knowledge of SAS programming(macro's)
• Must have 10 yrs of exp in clinical domain
• Strong knowledge of SDTM
• Create advanced SAS macros, templates, and utilities for efficient data processing
• Act as the primary programming point of contact for biostatisticians and study teams
• Perform peer review of code and documentation for accuracy and traceability
• Review CRF (Case Report Form) annotations and data specifications.
• Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines
• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, Clinical Research, or a related field.

Skill:

• Extensive programming experience in a clinical trial environment (CRO/Pharma).
• Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
• In-depth knowledge of CDISC standards and regulatory submission requirements
• Develop and maintain SDTM datasets using SAS programming.
• Create advanced SAS macros, templates, and reusable programming utilities.
• Perform clinical trial data manipulation, analysis, validation, and quality checks.
• Serve as a primary programming contact for biostatisticians and clinical study teams.
• Review CRF (Case Report Form) annotations and clinical data specifications.
• Ensure datasets and programming deliverables comply with CDISC SDTM/ADaM standards.
• Perform peer review of SAS programs, datasets, and supporting documentation.
• Ensure programming outputs maintain accuracy, consistency, traceability, and audit readiness.
• Support preparation of clinical data for FDA and other regulatory submissions.
• Identify and resolve programming, data, and standards-related issues.
• Collaborate with Data Management, Biostatistics, Clinical, Statistical Programming, and Regulatory teams.
• Develop documentation and programming specifications in accordance with study requirements.
• Ensure compliance with FDA, ICH, CDISC, and applicable clinical research standards.
• Contribute to process improvements and development of standardized programming solutions.