Data Standards Analyst

Summary Description
The 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 collaboration with the Head of CDARS, he/she sets the strategy and framework for governance of standards and actively engages in deployment of next generation process and technology. This role will focus on CDASH and SDTM standards within the assigned therapeutic area(s).

Detailed Description
Standards Development responsibilities include

Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
Data Collection
Data Review Rules

Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities

Pipeline responsibilities may include

Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC
Review and provide feedback on SDTM Trial Design Domains
Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions
Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation

Other responsibilities include:
representing AbbVie’s interests in industry standards development projects,
staying current with industry standards such as CDISC, and the regulatory requirements related to their use
identifying improvements to the processes and content of standards, and driving those improvements to completion