Senior Analyst, Data Standards - Remote

Overview

The Senior Data Standards Analyst within Clinical Data and Reporting Standards contributes to the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices.

In Short

• Actively participate with a cross-functional team to define SDTM mapping, data collection, and data review rules.
• Define ADaM mapping and derivation along with study-level tables and safety analysis displays.
• Ensure each standard is clearly defined with appropriate documentation.
• Educate the organization on the proper use of standards.
• Create and review SDTM Mapping Specifications and Trial Design Domains.
• Provide feedback on CRF design and SDTM datasets.
• Oversee the creation of SDTM define.xml and Clinical Study Data Reviewer’s Guides.
• Consult on conformance issues for SDTM and ADaM.
• Represent AbbVie in industry standards development projects.
• Identify and drive improvements to the processes and content of standards.

Requirements

• Experience leading development of standards for data collection and reporting.
• Experience with SDTM and CDASH.
• Active participation in CDISC teams preferred.
• Experience with preparing SDTM and ADaM datasets for regulatory submissions.
• Experience with standards related to eye care, neuroscience, or medical aesthetics is helpful.
• MS with 6 years or BS with 8 years of relevant clinical research experience.

Benefits

• Comprehensive benefits package including paid time off and medical insurance.
• Eligible for short-term incentive programs.