Allergan Aesthetics, an AbbVie Company · 1 day ago
Senior Manager, Data Standards - Hybrid
North Chicago, IL
Full-time
Hybrid
Senior Level, Lead/Staff
$121K/yr - $230K/yr
9+ years expAbbVie is a company focused on discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Manager, Clinical Data and Reporting Standards (CDARS) will lead the development of data and reporting standards for clinical trials, ensuring compliance with industry best practices and regulatory requirements.
BeautyManufacturingPharmaceuticalWellness
Responsibilities
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
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
May manage 3 or more direct reports
Qualification
Required
MS with 9 years of relevant clinical research experience, or
BS with 11 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 at least two of the following standards: CDASH, SDTM, ADaM, Analysis Results Metadata, or TLF standards
Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
Preferred
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
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
H1B Sponsorship
Allergan Aesthetics, an AbbVie Company 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
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Recent News
2025-12-04
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