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

• Lead development of data and reporting standards.
• Ensure conformance to CDISC standards.
• Implement strategies for governance of standards.
• Define standards for data collection and analysis.
• Create training materials for organizational use.
• Oversee regulatory submissions related to data standards.
• Mentor junior team members.
• Participate in cross-functional teams.
• Stay current with industry standards.
• Identify and drive process improvements.

Requirements

• Experience in clinical research and data standards.
• Proficiency in SDTM and CDASH.
• Experience with ADaM is beneficial.
• MS with 9 years or BS with 11 years of relevant experience.
• Active participation in CDISC teams preferred.

Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• Paid time off including vacation and holidays.
• 401(k) plan participation.
• Short-term incentive program eligibility.