Data Standards Analyst 

The 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.  In collaboration with the Head of CDARS, he/she sets the strategy and framework for governance of standards and actively engages in deployment of next generation process and technology.  This role will focus on CDASH and SDTM standards within the assigned therapeutic area(s).

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:
  • Data Collection
  • Data Review Rules
  • SDTM mapping
• Supporting 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

• 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
• Review and provide feedback on SDTM Trial Design Domains
• 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

Qualifications

• Experience leading development of standards for data collection, tabulation, analysis and/or reporting
• Experience with CDASH and SDTM
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful
• Active participation in CDISC teams preferred
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
• Experience with standards related to eye care, neuroscience, or medical aesthetics
• Experience with standards related to devices is helpful

Education and experience requirements

• MS with 6 years of relevant clinical research experience, or
• BS with 8 years of relevant clinical research experience