Manager, Clinical Data and Reporting Standards - SDTM Programming (Hybrid)

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 including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

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, ensuring conformance to CDISC standards and industry best practices, as well as pipeline-based SDTM development. 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.

Responsibilities

• Actively participate with a cross-functional team of subject matter experts to define one or more of the following types of standards within assigned therapeutic areas:
  • Data Collection
  • Data Review Rules
  • SDTM mapping
  • ADaM mapping and derivation
  • Study-level tables, listings, or figures
  • Product-level safety analysis displays
• Ensure each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities.
• Ensure consistency across standard types (e.g., eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.).
• Develop training materials for the organization on the proper use of standards in pipeline activities.
• Communicate ongoing standard development activities across the organization.
• Provide feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that supports 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 SDTM programming based on SDTM specifications.
• Oversee the creation of SDTM datasets, define.xml, annotated CRF, and Clinical Study Data Reviewers 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.
• Represent AbbVie’s interests in industry standards development projects.
• Stay current with industry standards such as CDISC and the regulatory requirements related to their use.
• Identify improvements to the processes and content of standards and drive those improvements to completion.

Qualifications

Minimum Qualifications:

• MS with 8 years of relevant clinical research experience, or BS with 10 years of relevant clinical research experience.
• Experience with SDTM is required.
• Experience leading development of standards for data collection, tabulation, analysis, and/or reporting.
• Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions.

Preferred Experience:

• Experience with CDASH is highly recommended.
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful.
• Active participation in CDISC teams is preferred.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.

Pay

The compensation range described is the range of possible base pay that AbbVie believes in good faith it will pay for this role at the time of posting, based on the job grade. Individual compensation paid within this range will depend on many factors, including geographic location, and may ultimately differ from the posted range. This range may be modified in the future.