Senior Manager, Clinical Data and Reporting Standards (Remote)
AbbVie
- San Francisco, CA
- Permanent
- Full-time
- 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.
- 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 at least two of the following standards: CDASH, SDTM, ADaM, Analysis Results Metadata, or TLF standards.
- Active participation in CDISC teams preferred.
- Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.