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Clinical statistical programmer (sas / cdisc)

Gaspar
E-Solutions
Anunciada dia 21 fevereiro
Descrição

Job Title: Clinical Statistical Programmer (SAS / CDISC) Location:Brazil Employment Type:Full-Time About the Role We are seeking a detail-oriented and experiencedClinical Statistical Programmerto 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 Responsibilities Transform raw clinical trial data into CDISC-compliantSDTMandADaMdatasets 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 to support automation, validation, and reproducible reporting Perform programming quality control (QC) and peer reviews to ensure accuracy, traceability, and compliance Prepare and maintain programming specifications, mapping documents, and annotated CRFs Troubleshoot complex data integration and derivation issues Support audits and regulatory inspections by ensuring reproducible code and complete documentation Required Qualifications Strong hands-on experience withSAS programming Solid expertise inCDISC standards (SDTM & ADaM) Experience generating TLFs for regulatory submissions In-depth knowledge of clinical trial data structures and submission processes Familiarity with Python or R for automation (preferred) Strong attention to detail and excellent documentation practices Preferred Qualifications Experience supporting regulatory submissions to agencies such as theU.S. Food and Drug Administration (FDA)and theEuropean Medicines Agency (EMA) Prior experience in a Pharmaceutical, Biotech, or CRO environment

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