Clinical Data Standards Lead

AbbVie; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Job summary

AbbVie seeks a Manager of Clinical Data and Reporting Standards to lead development of data and reporting standards aligned with CDISC (SDTM/ADaM) for AbbVie's clinical trials. The role guides governance, collaborates with cross-functional SMEs, and drives SDTM/ADaM programming and submissions support.

Responsibilities include defining data collection and review standards, creating documentation, and training the organization on standard usage while ensuring consistency across related standard

Qualifications

• MS with 8 years of relevant clinical research experience
• BS with 10 years of relevant clinical research experience
• Experience with SDTM programming 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

Responsibilities

• Actively participating with a cross-functional team of subject matter experts to define data-related standards including Data Collection, Data Review Rules, and SDTM mapping
• Participating in cross-functional teams to define ADaM mapping, study-level tables/listings/figures, and product-level safety analysis displays
• Ensuring standards are clearly defined with documentation of assumptions and decisions for pipeline activities
• Developing training materials on standards use in pipeline activities and communicating ongoing development activities across the organization
• Providing feedback on CRF design and SDTM datasets to ensure data supports regulatory requirements (CDISC standards) and AbbVie extensions

Education

MS with 8 years of relevant clinical research experience

BS with 10 years of relevant clinical research experience

Tools

SDTM programming

Standards development leadership

Job description

AbbVie seeks a Manager of Clinical Data and Reporting Standards to lead development of data and reporting standards aligned with CDISC (SDTM/ADaM) for AbbVie's clinical trials. The role guides governance, collaborates with cross-functional SMEs, and drives SDTM/ADaM programming and submissions support.

Responsibilities include defining data collection and review standards, creating documentation, and training the organization on standard usage while ensuring consistency across related standard