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Clinical statistical programmer (sas / cdisc)

Fazenda Rio Grande
Highbrow Technology Inc
Anunciada dia 21 fevereiro
Descrição

Job Title: Clinical Statistical Programmer (SAS / CDISC) Location - BrazilRole 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 annotatedCRFs · Troubleshoot complex data integration and derivation issues · Support audits and regulatory inspections with reproducible code and documentationRequired 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 practicesPreferred · Experience supporting FDA/EMA regulatory submissions · Prior experience in a Pharma, Biotech, or CRO environmentInterested candidates please share your profiles to ganapthikumar.m@highbrowtechnology.com

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