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Clinical statistical programmer (sas / cdisc)

Gaspar
E-Solutions
Anunciada dia 20 fevereiro
Descrição

Job Title: Clinical Statistical Programmer (SAS / CDISC)Location: Brazil Employment Type: Full-TimeAbout the RoleWe are seeking a detail-oriented and experienced Clinical Statistical Programmer to join our team in Brazil. The ideal candidate will play a key role in supporting clinical trial data standardization, statistical analysis, and regulatory submissions. This position requires strong expertise in SAS programming, CDISC standards (SDTM & ADaM), and the development of Tables, Listings, and Figures (TLFs).Key ResponsibilitiesTransform raw clinical trial data into CDISC-compliant SDTM and ADaM datasetsDevelop, validate, and maintain Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissionsWrite efficient, well-documented SAS programs for data cleaning, derivations, and reportingDevelop reusable Python or R scripts to support automation, validation, and reproducible reportingPerform programming quality control (QC) and peer reviews to ensure accuracy, traceability, and compliancePrepare and maintain programming specifications, mapping documents, and annotated CRFsTroubleshoot complex data integration and derivation issuesSupport audits and regulatory inspections by ensuring reproducible code and complete documentationRequired QualificationsStrong hands-on experience with SAS programmingSolid expertise in CDISC standards (SDTM & ADaM)Experience generating TLFs for regulatory submissionsIn-depth knowledge of clinical trial data structures and submission processesFamiliarity with Python or R for automation (preferred)Strong attention to detail and excellent documentation practicesPreferred QualificationsExperience supporting regulatory submissions to agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)Prior experience in a Pharmaceutical, Biotech, or CRO environment

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