Senior Analyst, Data Standards

Summary

Join AbbVie as a Senior Data Standards Analyst and contribute to the development of data and reporting standards for clinical trials. You will focus on CDASH and SDTM standards, actively participating in cross-functional teams to define standards for SDTM mapping, data collection, data review rules, ADaM mapping and derivation, and study-level outputs. Responsibilities include ensuring standards are clearly defined and documented, maintaining consistency across standard types, educating the organization on proper use, and communicating development activities. You will also provide feedback on SDTM mapping specifications, CRF design, and SDTM datasets, oversee the creation of documentation for regulatory submissions, and consult on conformance issues. This remote position requires experience in developing standards for data collection, tabulation, analysis, and reporting, along with expertise in SDTM and CDASH. AbbVie offers a comprehensive benefits package.

Requirements

• Experience leading development of standards for data collection, tabulation, analysis and/or reporting
• Experience with SDTM and CDASH
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
• MS with 6 years of relevant clinical research experience, or
• BS with 8 years of relevant clinical research experience

Responsibilities

• Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas: SDTM mapping
• Data Collection
• Data Review Rules
• Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas: 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
• Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)
• 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 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
• 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

Preferred Qualifications

• Active participation in CDISC teams
• Experience with standards related to eye care, neuroscience, or medical aesthetics
• Experience with standards related to devices
• Experience with ADaM, Analysis Results Metadata, or TLF standards

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)