Manager, Clinical Data and Reporting Standards - SDTM Programming; Hybrid

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

• Full-time
• Salary Min: 109500
• Salary Max: 208500
• Workday Global Grade: 18
• Compensation: USD 109,500 - USD 208,500 - yearly

The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of Abb Vie’s portfolio of clinical trials, ensuring conformance to CDISC standards and industry best practices.

• Actively participate with a cross-functional team of subject‑matter experts to define the following types of standards within the assigned therapeutic areas:
  • Data Collection
  • Data Review Rules
  • SDTM mapping
• Participate in a cross‑functional team of subject‑matter experts to define 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
• Ensure each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions 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 to 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 to support regulatory requirements and comply with CDISC standards (CDASH, SDTM and ADaM) and Abb Vie standard extensions to CDISC
• Review and provide feedback on SDTM Trial Design Domains
• Perform SDTM programming based on SDTM specifications
• Oversee the creation of SDTM datasets, 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 problems by correcting data or metadata, or providing an appropriate explanation

• Represent Abb Vie’s interests in industry standards development projects
• Stay current with industry standards such as CDISC and related regulatory requirements
• Identify improvements to the processes and content of standards and drive those improvements to completion

• 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 preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

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

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.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental and vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our long‑term incentive programs.

Abb Vie 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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