Clinical Statistical Programmer (SAS / CDISC)

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