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 ensuring 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:
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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:
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Data Collection
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Data Review Rules
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SDTM mapping
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:
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ADaM mapping and derivation
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Study-level tables, listings, or figures
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Product-level safety analysis displays
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Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities
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Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)
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Develop training materials to the organization on the proper use of standards in pipeline activities
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Communicate ongoing standard development activities across the organization
Pipeline responsibilities include:
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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
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Review and provide feedback on SDTM Trial Design Domains
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Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions
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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:
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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
Detailed Description
Qualifications:
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Experience leading development of standards for data collection, tabulation, analysis and/or reporting
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Experience with SDTM is required
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Experience with CDASH is highly recommended
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Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
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Active participation in CDISC teams preferred
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Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
Education and experience requirements:
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MS with 8 years of relevant clinical research experience, or
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BS with 10 years of relevant clinical research experience