Senior Manager, Clinical Data and Reporting Standards

Summary

Join AbbVie as a Senior Manager, Clinical Data and Reporting Standards (CDARS) and play a proactive role in developing data and reporting standards for clinical trials. You will ensure AbbVie's compliance with CDISC standards and best practices, implementing strategies for standards governance. Responsibilities include actively participating in cross-functional teams to define standards, developing training materials, and overseeing the creation of SDTM documentation for regulatory submissions. You will also provide feedback on CRF design and SDTM datasets, consult on conformance issues, and represent AbbVie's interests in industry projects. This remote US-based role requires a Master's degree with 9 years of experience or a Bachelor's degree with 11 years of relevant experience.

Requirements

• Masters degree with 9 years of relevant clinical research experience, or
• Bachelors degree 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 preparing SDTM datasets and documentation for regulatory submissions

Responsibilities

• Actively participate with a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas: SDTM mapping
• Actively participate with a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas: Data Collection
• Actively participate with a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas: Data Review Rules
• Participating in a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas: Study-level tables, listings, or figures
• Participating in a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas: Product-level safety analysis displays
• Participating in a cross-functional team of subject matter experts to define one or more of the following types of standards within the assigned therapeutic areas: ADaM mapping and derivation
• 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 (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
• Provide 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
• Represent AbbVie’s interests in industry standards development projects
• Stay current with industry standards such as CDISC, and the regulatory requirements related to their use
• Identify improvements to the processes and content of standards, and drive 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
• Long-term incentive programs