Senior Analyst, Data Standards

4 weeks ago

Chicago Illinois, United States AbbVie Full time
Job Description

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. This role will focus on CDASH and SDTM standards within therapeutic area(s) such as immunology, eye care, neuroscience, and medical aesthetics.

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:SDTM mapping

Data Collection

Data Review Rules

Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:ADaM mapping and derivation

Study-level tables, listings, or figures

Product-level safety analysis displays

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

Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)

Educate the organization on the proper use of standards in pipeline activities.

Communicate ongoing standard development activities across the organization.

Pipeline responsibilities may include:

Create, review and provide feedback on SDTM Mapping Specifications and Trial Design Domains

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

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

This role can be based remotely within the US.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)

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