Senior Manager, Data Standards

The Senior 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 ensures AbbVie’s conformance to CDISC standards and industry best practices. 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. Standards Development responsibilities include actively participating with a cross-functional team of subject matter experts to define standards, ensuring consistency across standard types, and developing training materials. Pipelineresponsibilities include creation, review, and feedback on SDTM Mapping Specifications and Trial Design Domains, providing feedback on CRF design and SDTM datasets, overseeing the creation of SDTM define.xml, and consulting on conformance issues for SDTM and/or ADaM. Other responsibilities include representing AbbVie’s interests in industry standards development projects.