The Senior Data Standards Analyst within Clinical Data and Reporting Standards contributes to 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 will focus on CDASH and SDTM standards within therapeutic area(s) such as immunology, oncology, eye care, neuroscience, and medical aesthetics. 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:
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.
Pipeline responsibilities may 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
This role can be remote based on candidate location.
Qualifications:
MS with 6 years of relevant clinical research experience or BS with 8 years of relevant clinical research experience
Expert level of knowledge of at least two areas of clinical data standards, and high level of knowledge in at least one additional area. Areas include CDASH, SDTM, ADaM, define.xml and controlled terminology.
Familiarity with other clinical data standards including BRIDG, ODM and SHARE
Experience in mapping and converting legacy data into SDTM domains for eCTD submissions.
Knowledge of international regulations, requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.
Experience with metadata repository technology and its application in clinical data standards processes, or experience with data standards governance
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.
