Principal, Clinical Data Standards - ADaM Metadata Lead

J&J is looking for experienced clinical trial programmers with in-depth understanding of ADaM standards in order to define and maintain ADaM metadata for therapeutic and disease area analysis standards. Lead and Principal positions available.


The job holder:

• Takes a leadership role in partnering with cross-functional stakeholders to drive and facilitate the development and utilization of standards to improve the efficiency of clinical research analysis and reporting processes and improve the consistency, quality, compliance, and value of clinical trial information.

• Leads the development and maintenance of Analysis Data Models (ADaM) metadata for global and disease area analysis standards / Data Lifecycle Plans (DLPs) supporting the data flow from data delivery to data analysis and reporting, with input from cross-functional subject matter experts (SMEs).

• Supports the functions adopting the standards in clinical trials, in close collaboration with other Clinical Data Standards (CDS) colleagues and ensures that team members understand the value of clinical standards and are trained on their use.

• Ensures adoption, conformance, and compliance metrics are evaluated with appropriate action taken.

• Develops deep expertise in industry standards related to Study Data Tabulation Model (SDTM), Controlled Terminologies (CT), ADaM and Therapeutic Area User Guides (TAUG).

• Focuses on analysis planning and reporting components of standards, particularly those related to data analysis deliverables, but will also have a strong understanding of the full scope of end-to-end standards, including inter-relationships, dependencies, and common elements.