Job Description
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.
Requirements:
- 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.
Numbers & Facts
| Location | San Francisco, CA |
Skills
Biostatisticsunmatched
Clinical Dataunmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Supportunmatched
Code of Federal Regulationsunmatched
Crystal Reportsunmatched
Data Cleaningunmatched
Data Managementunmatched
FTP (File Transfer Protocol)unmatched
FTP Clientsunmatched
GCP (Good Clinical Practices)unmatched
ICH Regulationsunmatched
Metricsunmatched
Oncologyunmatched
Operational Supportunmatched
People Managementunmatched
Problem Solving Skillsunmatched
Reconciliationunmatched
SAP BusinessObjectsunmatched
Secure/SSH File Transfer Protocol (SFTP)unmatched
Standard Operating Procedures (SOP)unmatched
Statistical Analysis System (SAS)unmatched
Statistical Programming Languagesunmatched
Validation Documentationunmatched
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