J&J Family of Companies Clinical Data Standards Architect - Data Analysis and Reporting in Beerse, Belgium
Janssen Pharmaceutica, a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical DataArchitect – Data Analysis & Reporting to be based in either Beerse, Belgium or Leiden, Netherlands.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more
The job holder defines and maintains standard metadata supporting the data flow from data delivery to data analysis and reporting and in designs, develops and maintains standard SAS code supporting the creation of analysis datasets and standard tables listings and figures (TLF). The job holder is responsible for implementing efficient standards that cover all trial types and trial designs and for the scientific and operational correctness of the metadata standards in support of the R&D portfolio of drug development programs. This person configures standards to the specific needs and requirements of a Therapeutic Area, Compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of metadata standards and standard SAS code. The job holder also supports the functions adopting the standards in the clinical trials, in close collaboration with the clinical data analysis team.
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).
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.
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.
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.
Must work closely together with the clinical data analysis teams who facilitate the content definition and design of these standards (e.g. display mock-ups).
Delivers the standard programs and macros with related usage and implementation guidelines and documentation for correct adoption in the clinical studies.
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.
Pre-configures the standards in line with the data lifecycle plan, which documents the standard data collection, analysis and reporting strategy and content for a drug development programs, 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.
· BS/BA degree in life sciences or computer science or equivalent by work experience
· 2 years of relevant operanal experience in statistical programming
· Relevant operational experience in clinical data standards is preferred
· Experience with Clinical Data Management / Statistical Programming
· Experience with SAS based systems
· Experience with CDISC standards (SDTM, ADaM, define.xml, etc.)
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)
Clinical Data Management