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Clinical statistical programmer (sas / cdisc) || brazil

Fazenda Rio Grande
Ampstek
Anunciada dia 20 fevereiro
Descrição

Role :: Clinical Statistical Programmer (SAS / CDISC)Location :: Brazil/RemoteDuration :: Long Term Contract Role SummaryWe 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 documentationRequired 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 practicesPreferred• Experience supporting FDA/EMA regulatory submissions• Prior experience in a Pharma, Biotech, or CRO environment

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