Clinical Data Standards Leader – CDISC/SDTM Expert

AbbVie; Florham Park (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

Dental insurance

401(k)

Job summary

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive data and reporting standards for clinical trials and ensure conformance to CDISC standards. You will lead SDTM/ADaM development, define standards, document decisions, and coordinate across therapeutic areas to support regulatory submissions.

Responsibilities include SDTM programming, defining datasets, and creating guides for FDA/PMDA submissions, while advancing training and communication across the

Qualifications

• MS with 8 years of relevant clinical research experience.
• 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.

Responsibilities

• Actively participating with a cross‑functional team of subject matter experts to define standards within the assigned therapeutic areas (Data Collection, Data Review Rules, SDTM mapping).
• Participating in cross‑functional teams to define ADaM mapping, study tables/listings/figures, or product safety displays.
• Ensuring standards are clearly defined with documentation of assumptions and decisions for pipeline activities.
• Ensuring consistency across standard types (e.g., eCRF with TLF, SDTM with ADaM).
• Develop training materials on proper use of standards in pipeline activities and communicate ongoing activities.
• Providing feedback on CRF design and SDTM datasets to support regulatory requirements; review SDTM Trial Design Domains; SDTM programming; oversee creation of SDTM datasets, define.xml, annotated CRF and CDS reviewers' guides; consult on conformance issues.

Skills

SDTM mapping

ADaM mapping

Data collection standards

Data review rules

Regulatory submissions

Education

MS in a related field

BS in a related field

Job description

AbbVie is seeking a Manager, Clinical Data and Reporting Standards (CDARS) to drive data and reporting standards for clinical trials and ensure conformance to CDISC standards. You will lead SDTM/ADaM development, define standards, document decisions, and coordinate across therapeutic areas to support regulatory submissions.

Responsibilities include SDTM programming, defining datasets, and creating guides for FDA/PMDA submissions, while advancing training and communication across the