The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensures AbbVie’s conformance to CDISC standards and industry best practices. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS, and actively engages in deployment of next generation process and technology.

　　Standards Development responsibilities include:

　　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.

　　Pipeline responsibilities include:

　　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.

　　Other responsibilities include:

　　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

　　Qualifications:

　　MS with 8 years of relevant clinical research experience, or

　　BS with 10 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

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.