SDTM Programmer

Overview: 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