Senior Manager, Clinical Data Standards & Reporting

AbbVie; California (MO); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie seeks a Manager of Clinical Data and Reporting Standards to drive governance and deployment of CDISC-based standards across AbbVie’s clinical trials. You will work with cross-functional teams to define SDTM/ADaM standards, generate documentation, and support regulatory submissions.

Responsibilities include SDTM mapping, data review rule development, trial design domain feedback, and cross-functional communication of standards initiatives.

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 participate in development of data and reporting standards within therapeutic areas (Data Collection, Data Review Rules, SDTM mapping).
• Define ADaM mapping and derivation, study-level tables, listings or figures, and product-level safety displays.
• Oversee SDTM datasets, define.xml, annotated CRF and submission deliverables for FDA/PMDA.
• Ensure standards are clearly defined with documentation of assumptions and decisions.

Skills

SDTM

CDISC

ADaM

Data standards

Regulatory submissions

Education

MS with 8 years of relevant clinical research experience

BS with 10 years of relevant clinical research experience

Job description

AbbVie seeks a Manager of Clinical Data and Reporting Standards to drive governance and deployment of CDISC-based standards across AbbVie’s clinical trials. You will work with cross-functional teams to define SDTM/ADaM standards, generate documentation, and support regulatory submissions.

Responsibilities include SDTM mapping, data review rule development, trial design domain feedback, and cross-functional communication of standards initiatives.