AbbVie · 1 day ago
Manager, Data Standards - Hybrid
North Chicago, IL
Full-time
Hybrid
Mid, Senior Level, Lead/Staff
$106K/yr - $202K/yr
8+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Manager, Clinical Data and Reporting Standards (CDARS) will lead the development of data and reporting standards for clinical trials, ensuring compliance with industry standards and best practices.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
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; SDTM mapping
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.)
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 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
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
Qualification
Required
MS with 8 years of relevant clinical research experience, or
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 preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
Preferred
Experience with CDASH is highly recommended
Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
Active participation in CDISC teams preferred
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-11
2026-01-09
2026-01-09
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