Role :: Clinical Statistical Programmer (SAS / CDISC)
Location :: Brazil/Remote
Duration :: Long Term Contract
Role Summary
We are seeking a detail-oriented Clinical Statistical Programmer to support clinical trial data standardization, analysis, and regulatory submissions. The ideal candidate will have strong expertise in CDISC standards (SDTM & ADaM), SAS programming, and generation of Tables, Listings, and Figures (TLFs), along with experience in quality control and submission readiness.
Key Responsibilities
• Transform raw clinical trial data into CDISC-compliant SDTM and ADaM datasets
• Develop, validate, and maintain Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions
• Write efficient, well-documented SAS programs for data cleaning, derivations, and reporting
• Develop reusable Python or R scripts for automation, validation, and reproducible reporting
• Perform programming QC and peer reviews to ensure accuracy and traceability
• Prepare and maintain programming specifications, mapping documents, and annotated CRFs
• Troubleshoot complex data integration and derivation issues
• Support audits and regulatory inspections with reproducible code and documentation
Required Qualifications
• Strong experience with SAS programming
• Hands-on experience with CDISC standards (SDTM & ADaM)
• Experience generating TLFs for regulatory submissions
• Knowledge of clinical trial data structures and submission processes
• Familiarity with Python or R for automation (preferred)
• Strong attention to detail and documentation practices
Preferred
• Experience supporting FDA/EMA regulatory submissions
• Prior experience in a Pharma, Biotech, or CRO environment