Job Description

Senior Data Standards Analyst

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

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 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:
• 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

Qualifications:

• Experience leading development of standards for data collection, tabulation, analysis and/or reporting
• Experience with SDTM and CDASH
• 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 is helpful
• Experience with standards related to devices is helpful
• Experience with ADaM, Analysis Results Metadata, or TLF standards 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

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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