AbbVie Verified 2h ago
Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)
Irvine, CA, United States Hybrid
$109,500–$208,500 a yearPay$109,500–$208,500
TypeFull-time
Work settingHybrid
Verified listing
JobFig found this opening at its original source and checks that it remains available.
About the role
The 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 as well as pipeline based SDTM development. 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.
What you'll bring
- MS with 8 years of relevant clinical research experience, or
- BS with 10 years of relevant clinical research experience
- Experience with SDTM is required
- Experience leading development of standards for data collection, tabulation, analysis and/or reporting
- Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
- Experience with CDASH is highly recommended
- Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
- Active participation in CDISC teams preferred
Benefits
401(k)Paid Time Off