Senior Manager, Data Standards

Summary

Join AbbVie as a Senior Manager, Clinical Data and Reporting Standards (CDARS) and play a key role in developing and implementing data and reporting standards for clinical trials. You will actively participate in cross-functional teams, defining standards for various aspects of clinical data, ensuring consistency across different standard types, and developing training materials. Responsibilities include reviewing SDTM mapping specifications, providing feedback on CRF design, overseeing the creation of SDTM documentation for regulatory submissions, and consulting on conformance issues. You will also represent AbbVie in industry standards development projects and mentor junior team members. This remote position requires experience leading standards development in clinical research, proficiency with SDTM, and a relevant educational background.

Requirements

• Experience leading development of standards for data collection, tabulation, analysis and/or reporting
• Experience with SDTM is required
• Experience with preparing SDTM datasets and documentation for regulatory submissions
• MS with 9 years of relevant clinical research experience, or
• BS with 11 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: Study-level tables, listings, or figures
• Product-level safety analysis displays
• ADaM mapping and derivation
• 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.)
• Develop training materials to 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
• Mentor junior team members

Preferred Qualifications

• Experience with CDASH is highly recommended
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful
• Active participation in CDISC teams preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs