Senior Analyst, Data Standards
Company:
Location:US
Seniority level:Senior, MS with 6 years of relevant clinical research experience, or BS with 8 years of relevant clinical research experience
Experience:MS with 6 years of relevant clinical research experience, or BS with 8 years of relevant clinical research experience
Skills:
Data AnalysisData visualizationData modelingData management
Requirements:
Experience leading development of standards for data collection, tabulation, analysis and/or reporting Experience with SDTM and CDASH Active participation in CDISC teams preferred Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
Responsibilities:
Define standards within assigned therapeutic areas: SDTM mapping, Data Collection, Data Review Rules, 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 Educate the organization on the proper use of standards in pipeline activities Communicate ongoing standard development activities across the organization Create, review and provide feedback on SDTM Mapping Specifications and Trial Design Domains Providing feedback on CRF design and SDTM datasets 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 Represent 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
