Manager, Clinical Data and Reporting Standards - Remote

Overview

The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensures AbbVie’s conformance to CDISC standards and industry best practices.

In Short

• Actively participate in the development of data and reporting standards.
• Implement strategy and framework for governance of standards.
• Define standards for SDTM mapping, data collection, and data review rules.
• Ensure consistency across standard types.
• Develop training materials on the use of standards.
• Create and review SDTM Mapping Specifications.
• Consult on conformance issues for SDTM and ADaM.
• Mentor junior team members.
• Stay current with industry standards and regulatory requirements.
• Identify and drive improvements to standards processes.

Requirements

• Experience leading development of standards for data collection and reporting.
• Experience with SDTM required; CDASH recommended.
• Experience with ADaM and regulatory submissions preferred.
• MS with 8 years or BS with 10 years of relevant experience.
• Active participation in CDISC teams preferred.

Benefits

• Comprehensive benefits package including medical/dental/vision insurance.
• Paid time off including vacation and sick leave.
• Participation in short-term and long-term incentive programs.