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:
Template programs and macros for dataset creation
and TLF generation
SAS macros for computational algorithms, derivations
and wrapper code.
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).
holder delivers the standard programs and macros with related usage
and implementation guidelines and documentation for correct adoption in the
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
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).
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. QualificationsRESPONSIBILITY
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
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.
AND EXPERIENCE REQUIREMENTS
skills and experience requirements
BS/BA degree in life sciences or computer science
or equivalent by work experience
2 years of relevant operational experience in statistical
Relevant operational experience in clinical data
standards is preferred
Proven people management skills
Proven knowledge of good statistical programming
Other relevant skills and experiences and
skills taken into consideration.
Experience with Clinical Data Management / Statistical Programming
Experience with SAS based systems
Experience with CDISC standards (SDTM, ADaM, define.xml, etc.)
Experience in prioritizing and managing multiple tasks simultaneously.
Outstanding written and verbal communication skills in English
J&J (China) Investments Ltd (7046)Job Function
Clinical Data ManagementRequisition ID