Job Title: Clinical Statistical Programmer (SAS / CDISC)
Location: Brazil (Remote)
Duration: Long Term Contract
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-compliantSDTM and ADaM datasets
Develop, validate, and maintainTables, Listings, and Figures (TLFs)for clinical study reports and regulatory submissions
Write efficient, well-documentedSAS programsfor data cleaning, derivations, and reporting
Develop reusablePython or R scriptsfor automation, validation, and reproducible reporting
Perform programmingQC and peer reviewsto ensure accuracy and traceability
Prepare and maintainprogramming 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 withSAS programming
Hands-on experience withCDISC standards (SDTM & ADaM)
Experience generatingTLFs for regulatory submissions
Knowledge of clinical trial data structures and submission processes
Familiarity withPython or Rfor 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