SDTM Programmer

About

We are seeking an experienced SDTM Programmer to support clinical trial data standardization and regulatory submissions. This individual will be responsible for transforming raw clinical data into CDISC-compliant SDTM datasets and ensuring high-quality, submission-ready deliverables. The role requires strong collaboration with Data Management, Biostatistics, and Clinical teams.

Key Responsibilities

• Develop, validate, and maintain SDTM datasets in compliance with CDISC standards
• Convert raw clinical trial data into SDTM format using SAS programming
• Create and maintain SDTM specifications (mapping specifications, define.xml, SDRG)
• Perform quality control (QC) and validation of SDTM datasets and outputs
• Ensure datasets meet regulatory submission requirements (FDA, EMA)
• Collaborate with Data Management to review CRFs and ensure proper data collection for SDTM mapping
• Work closely with Biostatistics and ADaM programmers to support downstream analyses
• Troubleshoot data issues and ensure data integrity, consistency, and traceability
• Support submission activities, including reviewer’s guides and regulatory documentation
• Contribute to process improvements and standardization initiatives

Required Qualifications

• Bachelor’s degree in Statistics, Computer Science, Life Sciences, or related field
• 6-7+ years of SAS programming experience within the pharmaceutical or biotech industry
• Hands-on experience with CDISC SDTM standards and implementation
• Strong knowledge of clinical trial data structures and data flow
• Experience creating define.xml and SDTM documentation (SDRG)
• Familiarity with regulatory submission requirements (FDA, EMA)
• Experience working in a CRO or sponsor environment
• Strong attention to detail and problem-solving skills and lead experience
• Excellent communication and ability to work cross-functionally

Preferred Qualifications

• Experience with ADaM datasets and TLF generation
• Oncology or other therapeutic area experience
• Experience with Pinnacle 21 (validation tool)
• Knowledge of additional programming languages (e.g., R) is a plus
• Prior experience supporting NDA/BLA submissions