Clinical Statistical Programmer (sas / Cdisc)

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 & ADa M), 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 ADa M 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 & ADa M)

· 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