
Clinical Data Analyst
1 week ago
Key Responsibilities
- Programming & Data Handling Write SAS programs to manage, transform, and analyze clinical trial data.
- SDTM Development Map raw data into SDTM domains following CDISC standards.
- ADaM Dataset Creation – Develop analysis-ready datasets for statistical analysis and regulatory reporting.
- TLF Generation – Produce Tables, Listings, and Figures (TLFs) for clinical study reports and FDA/EMA submissions.
- Validation & QC – Perform independent programming checks to ensure accuracy and compliance.
- Documentation – Maintain specifications, programming logs, and compliance documents for audits
- Raw Data Mapping – Extract, clean, and map raw clinical data from multiple sources (EDC, lab, safety) into CDISC-compliant SDTM datasets.
- Dataset Specifications – Write and review SDTM/ADaM specifications and define XML files for regulatory compliance.
- Analysis Dataset Programming – Create ADaM datasets to support efficacy, safety analysis.
- Statistical Outputs – Generate TLFs using ADaM datasets for Clinical Study Reports (CSRs).
- Regulatory Submission Support – Prepare submission-ready datasets (SDTM/ADaM) and documentation , reviewer's guides) for FDA/EMA.
- Standards Compliance – Ensure datasets follow CDISC, FDA, and sponsor-specific standard
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