Clinical Data Analyst

2 weeks ago

Hyderabad, Telangana, India Whiteboard Global Learning And Development Private Full time ₹ 5,00,000 - ₹ 10,00,000 per year

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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