A Clinical Data Analyst is responsible for collecting, reviewing, analyzing, and validating clinical trial data to ensure accuracy, consistency, completeness, and compliance with regulatory requirements. The role involves identifying data discrepancies, performing data quality checks, preparing reports, and collaborating with clinical research, biostatistics, and clinical operations teams to support reliable clinical study outcomes. The ideal candidate has strong analytical skills, knowledge of clinical data management processes, and familiarity with clinical research standards and regulatory guidelines.
- Bachelor's or Master's degree in a relevant field or equivalent experience
- 7+ years of clinical data programming experience, with a minimum of 5 years in oncology
- Hands-on experience across Phase I, II, and III oncology trials
- Proficiency in SAS; working knowledge of Medidata Rave, Business Objects, and Crystal Reports
- Familiarity with CDISC, 21 CFR Part 11, ICH, and GCP guidelines
- Experience with sFTP/FTP tools and vendor data portals
- Develop, maintain, and execute SAS programs to support external data transfers, including validation against vendor transfer specifications
- Generate and maintain Data Review Listings (DRLs) and Study Health Metrics (SHMs) in accordance with study timelines
- Perform peer review of DRLs and data reconciliation reports
- Monitor automated job logs and resolve issues as needed
- Retrieve and post external vendor data using sFTP/FTP clients and vendor portals
- Collaborate with data managers, statistical programmers, biostatistics, and clinical operations to support data cleaning and integrity activities
- Contribute to the development and maintenance of SAS macro programs and departmental programming standards
- Participate in SOP and work instruction development, including program validation and documentation
- Provide guidance and support to junior members of the data programming team