Job Title: Clinical Statistical Programmer (SAS / CDISC)
Location:Brazil
Employment Type:Full-Time
About the Role
We are seeking a detail-oriented and experiencedClinical Statistical Programmerto 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-compliantSDTMandADaMdatasets
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 withSAS programming
Solid expertise inCDISC 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 theU.S.
Food and Drug Administration (FDA)and theEuropean Medicines Agency (EMA)
Prior experience in a Pharmaceutical, Biotech, or CRO environment