Senior Manager, Data Standards (Remote)

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 SDTM is required Experience with CDASH is highly recommended Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful Active participation in CDISC teams preferred Experience with preparing SDTM datasets and documentation for regulatory submissions

Develop data and reporting standards for clinical trials Ensure conformance to CDISC standards and industry best practices Implement strategy and framework for governance of standards Define standards for SDTM mapping, data collection, data review rules, study-level tables, listings, figures, product-level safety analysis displays, and ADaM mapping and derivation Ensure consistency across standard types Develop training materials on standards usage Communicate standard development activities Create, review, and provide feedback on SDTM Mapping Specifications and Trial Design Domains Provide feedback on CRF design and SDTM datasets Oversee creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides Consult on conformance issues for SDTM and/or ADaM and resolve problems Represent AbbVie's interests in industry standards development projects Stay current with industry standards and regulatory requirements Identify and drive improvements to standards processes and content Mentor junior team members