PRINCIPALRESPONSIBILITIES The job holder defines and maintains standard clinical data analysis and results metadata for use in clinical trials and the mapping -
and derivation metadata used for automating the data flow from Study Data Tabulation Datasets (SDTM) to Analysis Datasets and Analysis Results (ADaM).
The job holder consults with the Clinical Data Analysis Standards team for scientific correctness of the metadata, with the Clinical Data Collection Standards team for scientifically correct traceability to the delivery metadata standards and with the Standards Regulatory Intelligence team for the compliance of the metadata with industry regulations.
The job holder documents, implements and maintains scientifically and operationally correct traceability between domain and variable metadata across the different metadata models.
The job holder defines the standard metadata compliant to the industry standards and health authority regulations.The job holder oversees the maintenance of the metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio.
To that end the job holder applies formal change management control and versioning of the standards and the job holder governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
The job develops and maintains standard code supporting the data flow from data delivery (SDTM) to study report. Examples are :
The job holder works closely together with the clinical data analysis teams who facilitate the content definition and design of these standards (e.
g. display mock-ups). The job holder delivers the standard programs and macros with related usage and implementation guidelines and documentation for correct adoption in the clinical studies.
The job holder maintains the standard code over time to meet additional scientific or operational requirement supporting the R&D portfolio and applies formal change management control and versioning of the deliverables.
The job holder develops and tests programs and macros compliant to Janssen SOP, guidelines and conventions, that can be easily shared and maintained.
To that end, the job holder collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR) and Quantitative Sciences (QS).
The goal is to develop and maintain code that is generic and that can run on many study designs and meet many study specific situations based on high reliable study metadata specifying the design and study specific situations.
The job holder pre-configures the standards in line with the data lifecycle plan while maintaining the traceability and lineage of the data.
The job holder documents and manages correctly the lineage between master standards and the many pre-configured standards.
The job holder provides the necessary support to the clinical analysis team who facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO).
The job holder is responsible in acquiring and maintaining deep expertise in the various code development systems applied in the clinical trials such as SAS, LSAF and Pinnacle 21, and in CDISC standards such as SDTM, ADaM, Controlled terminology and define.
xml. The job holder is encouraged to become member of industry initiatives related to the development of industry standards.
RESPONSIBILITY FOR OTHERS (If applicable)
The job holder will interact with other members of the Clinical Development Standards organization and hence needs a workable knowledge of end-
to-end (E2E) Data & Analysis Standardization projects, especially those that are dependent on the data collection and delivery standards.
Future looking, the job holder evaluates and implements new industry trend such as biomedical concepts in the metadata structures to create additional efficiencies and quality in applying standards in clinical trials.
In this context, biomedical concepts are the relationships and the logic for related groupings of granular concepts in real-
world scenarios. EDUCATION AND EXPERIENCE REQUIREMENTS
Education, skills and experience requirements
Other relevant skills and experiences and skills taken into consideration.