Manager, Data Standards - Hybrid

Join to apply for the Manager, Data Standards - Hybrid role at Abb Vie

$/yr – $/yr

Abb Vie'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 Abb Vie, please visit us at

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.

• Actively participating with a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas:
  Data Collection;
  Data Review Rules; SDTM mapping
• Participating in a cross-functional team of subject matter experts to define one or 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.)
• Develop training materials to the organization on the proper use of standards in pipeline activities
• Communicate ongoing standard development activities across the organization

• Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that supports regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and Abb Vie 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

• Representing Abb Vie’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

• MS with 8 years of relevant clinical research experience
• BS with 10 years of relevant clinical research experience
• Experience leading development of standards for data collection, tabulation, analysis and/or reporting
• Experience with SDTM is required
• Experience with CDASH is highly recommended
• Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
• Active participation in CDISC teams preferred
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

• Mid-Senior level

• Full-time

• Information Technology
• Pharmaceutical Manufacturing and Biotechnology Research

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only – to learn more, visit

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