Senior Manager, Data Standards - Hybrid

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

**This is a hybrid based position. Candidates must be local and work out of North Chicago, IL; Florham Park, NJ; San Francisco, CA or Irvine, CA. 

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 ensuring AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.

Standards Development responsibilities include: 

• Leading or participating in a cross-functional team of subject matter experts to define at least one of the following types of standards within the assigned therapeutic area: Data Collection; Data Review Rules; SDTM mapping; 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
• Support educating the organization on the proper use of standards in pipeline activities by contributing to the development of training materials
• Communicate ongoing standard development activities across the organization

Pipeline responsibilities 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<