Clinical Data Analyst

SimulStat • Contract • Telecommute, Telecommute • 3w ago

Key Responsibilities

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

Qualifications

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