Manager, Clinical Data & Reporting Standards - SDTM Programming (Hybrid)
AbbVie
Summary
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.
Job description
Standards Development Responsibilities
- Actively participate with a cross-functional team of subject matter experts to define standards within assigned therapeutic areas: Data Collection, Data Review Rules, SDTM mapping
- Participate in a cross-functional team of subject matter experts to define standards: ADaM mapping and derivation, Study-level tables, listings, or figures, Product-level safety analysis displays
- Ensure each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities
- Ensure consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards)
- Develop training materials to the organization on the proper use of standards in pipeline activities
- Communicate ongoing standard development activities across the organization
Pipeline Responsibilities
- Provide feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that supports 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
- SDTM Programming based on SDTM specifications
- Oversee the creation of SDTM datasets, 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
Other Responsibilities
- Represent AbbVie's interests in industry standards development projects
- Stay current with industry standards such as CDISC, and the regulatory requirements related to their use
- Identify improvements to the processes and content of standards, and drive those improvements to completion
Requirements
- MS with 8 years of relevant experience, OR BS with 10 years of relevant experience
- Experience with SDTM programming 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
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.