Job Title: Clinical Statistical Programmer (SAS / CDISC)
Location - Brazil
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
Interested candidates please share your profiles to ganapthikumar.m@highbrowtechnology.com