- Lead or participate in defining data and reporting standards in support of AbbVie's clinical trials
- Implement strategies for governance of standards as set by CDARS leadership
- Engage in deploying next-generation processes and technology
- Data Collection
- Data Review Rules
- SDTM mapping
- ADaM mapping and derivation
- Study-level tables, listings, or figures
- Product-level safety analysis displays
- Provide feedback on CRF design and SDTM datasets
- Review and provide feedback on SDTM Trial Design Domains
- Oversee the creation of SDTM and annotated CRF for regulatory submissions
- Consult on conformance issues for SDTM and/or ADaM
- Represent AbbVie in industry standards development projects
- Stay updated on industry standards and regulatory requirements
- Identify and drive improvements to standards processes
- Manage a team of direct reports
- MS with 9 years or BS with 11 years of clinical research experience
- Experience in developing data standards for clinical research
- Experience with CDASH, SDTM, ADaM, or TLF standards
- Active participation in CDISC teams preferred
- Experience preparing SDTM and/or ADaM datasets for regulatory submissions
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Senior Manager, Clinical Data and Reporting Standards - San Francisco, United States - AbbVie
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Description
Senior Manager, Clinical Data and Reporting Standards (CDARS) - AbbVie
AbbVie is on a mission to discover and deliver innovative medicines and solutions that address serious health issues today and medical challenges of tomorrow. With a focus on key therapeutic areas such as immunology, oncology, neuroscience, and eye care, AbbVie's Allergan Aesthetics portfolio offers products and services that make a remarkable impact on people's lives.
Job Description:
Standards Development Responsibilities:
Pipeline Responsibilities:
Other Responsibilities:
Qualifications:
Additional Information:
The compensation range for this role is based on the company's good faith estimate and may vary based on factors such as location. Eligible employees will receive benefits including paid time off, medical/dental/vision insurance, and participation in incentive programs.
Note:
AbbVie is committed to diversity, innovation, and transforming lives. The company values integrity and does not discriminate in employment based on protected group status.