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Interviews

Clinical Data Analyst - Intern

Whiteboard Global Learning And Development Private

0 - 1 years

|

0 Lacs

Posted:5 hours ago| Platform:

Apply

Skills Required

statistics life sciences data analytics biostatistics sas pharmacovigilance clinical trials sql data science r excel clinical research drug safety healthcare clinical data management bioinformatics python

Work Mode

Remote

Job Type

Internship

Job Description

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 (define.xml, reviewer’s guides) for FDA/EMA.
Standards Compliance
– Ensure datasets follow CDISC, FDA, and sponsor-specific standard

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