Clinical Data Analyst

  • Contract
  • San Francisco Bay Area,California

SimulStat

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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

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