Manager, Data Standards - Hybrid
a day ago
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HybridFull-timeSenior
Summary
AbbVie is seeking a Manager, Data Standards to join their team in a hybrid role based in North Chicago, IL, Florham Park, NJ, San Francisco, CA, or Irvine, CA. The position involves developing data and reporting standards for clinical trials and ensuring compliance with CDISC standards.
About the Role
As the Manager, Data Standards, you will proactively participate in the development of data and reporting standards in support of AbbVie's clinical trials portfolio. Your responsibilities will include collaborating with cross-functional teams to define standards, ensuring consistency across standard types, developing training materials, and communicating ongoing standard development activities. You will also provide feedback on CRF design and SDTM datasets, oversee the creation of regulatory submission documents, and represent AbbVie's interests in industry standards development projects.
About You
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.
Preferred:
- 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.
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligibility to participate in short-term and long-term incentive programs.
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North Chicago, IL