Senior Manager, Data Standards - Remote

Overview

The Senior 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

• Participate in the development of data and reporting standards.
• Implement governance strategies for standards development.
• Engage in deploying next-generation processes and technology.
• Ensure conformance to CDISC standards.
• Develop training materials on standards use.
• Oversee the creation of regulatory submission documents.
• Mentor junior team members.
• Stay current with industry standards and regulatory requirements.
• Identify and drive improvements in standards processes.
• Represent AbbVie in industry standards development projects.

Requirements

• Experience leading development of data collection standards.
• Experience with SDTM is required.
• Experience with CDASH is highly recommended.
• Experience with ADaM and regulatory submissions is helpful.
• MS with 9 years or BS with 11 years of clinical research experience.

Benefits

• Comprehensive benefits package including medical and dental insurance.
• Paid time off including vacation and sick leave.
• 401(k) plan eligibility.
• Participation in short-term incentive programs.