Job Title: Clinical Statistical Programmer (SAS / CDISC)
Location - Brazil (Remote)
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