StatisticalProgrammer

## Accountabilities Develop, maintain, and validate annotated Case Report Forms (aCRFs), SDTM and ADaM datasets, and statistical outputs including Tables, Listings, and Figures (TLFs) across clinical studies. Program and validate datasets and deliverables in alignment with CDISC standards (SDTM/ADaM), study protocols, and statistical analysis plans. Support data management activities by assisting in data cleaning, issue tracking, and resolution in collaboration with biostatistics and programming teams. Generate and maintain define.xml files, reviewer guides, and related documentation in compliance with regulatory submission standards. Apply SAS programming and global macros to improve efficiency and ensure consistency in statistical programming deliverables. Validate SDTM and ADaM datasets using Pinnacle 21 and ensure resolution of all identified issues. Contribute to the development and improvement of internal programming standards, templates, and automation tools. Collaborate with cross-functional teams to ensure timely, high-quality deliverables aligned with project timelines and budgets. Stay updated on regulatory requirements, CDISC standards, and industry best practices in clinical programming. Requirements: Bachelor’s degree in Statistics, Computer Science, or a related field; Master’s degree is an advantage. Minimum 1 year of experience in clinical research within pharmaceutical, biotech, or CRO environments, including hands-on statistical programming experience. Strong proficiency in SAS programming; SAS certification is a plus. Solid understanding of CDISC standards (SDTM, ADaM) and clinical data submission requirements. Familiarity with clinical trial processes, SAPs, TLF shells, and regulatory guidelines (ICH, FDA, Health Canada). Knowledge of XML programming and Pinnacle 21 validation tools is an advantage. Strong attention to detail, organization, and ability to manage multiple priorities in a fast-paced environment. Ability to work independently as we