Clinical Data Analyst

Katalyst-Healthcares-; Port Reading (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst-Healthcares- in New Jersey is seeking a Senior Clinical Data Programmer to develop, maintain, and execute SAS programs supporting external data transfers and study data integrity. You will generate DRLs and SHMs, peer review data reconciliation, monitor job logs, and collaborate with data managers, statisticians, biostatisticians, and clinical operations.

Oncology-focused, 7+ years of experience required.

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.

Responsibilities

• Develop, maintain, and execute SAS programs to support external data transfers, including validation against vendor transfer specifications
• Generate and maintain DRLs and 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

Skills

SAS programming

Medidata Rave

Business Objects

Crystal Reports

CDISC

GCP/ICH

Education

Bachelor's or Master's degree in a relevant field

Tools

sFTP/FTP tools

Vendor data portals

Job description

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