Job Title: Clinical Statistical Programmer (SAS / CDISC)
Location: Brazil
Employment Type: Full-Time
About the Role
We are seeking a detail-oriented and experienced Clinical Statistical Programmer to join our team in Brazil. The ideal candidate will play a key role in supporting clinical trial data standardization, statistical analysis, and regulatory submissions. This position requires strong expertise in SAS programming, CDISC standards (SDTM & ADaM), and the development of Tables, Listings, and Figures (TLFs).
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 to support automation, validation, and reproducible reporting
* Perform programming quality control (QC) and peer reviews to ensure accuracy, traceability, and compliance
* Prepare and maintain programming specifications, mapping documents, and annotated CRFs
* Troubleshoot complex data integration and derivation issues
* Support audits and regulatory inspections by ensuring reproducible code and complete documentation
Required Qualifications
* Strong hands-on experience with SAS programming
* Solid expertise in CDISC standards (SDTM & ADaM)
* Experience generating TLFs for regulatory submissions
* In-depth knowledge of clinical trial data structures and submission processes
* Familiarity with Python or R for automation (preferred)
* Strong attention to detail and excellent documentation practices
Preferred Qualifications
* Experience supporting regulatory submissions to agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
* Prior experience in a Pharmaceutical, Biotech, or CRO environment