Clinical Data Management: Senior Technical Data Architect, Data Engineering (SDTM Programming)
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.
Within our Integrated Data Analytics & Reporting (IDAR) Data Management-Clinical Data Standards (DM-CDS) organization we are currently looking for individuals with the aptitude and motivation to further nurture and contribute to the growth of our Technical Data Architect (TDA) , Data Engineering group This is an exciting opportunity to be part of a new innovative technical data management team that is pivotal in defining our end to end automated data flow supporting next generation data strategies.
The position is primarily accountable for providing hands on delivery and oversight of technical clinical data management activities integrating Rave EDC, eSOURCE, third party data, mapping and transformation of data to CDISC SDTM submission-ready tabulation packages as well as CRO oversight for outsourced trials.
Principle Responsibilities Include; Development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for purpose data models and transfer intervals. Create and review specifications
for mapping internal data review model for safety and quality review as well as submission-ready CDISC SDTM. Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive decision making, etc.) and compliant for database lock and submission-ready tabulation packages.
Develop and maintain working knowledge and expertise in programming languages utilized in current data management (SAS, SQL, etc.) and apply continuous learning as part of next generation data strategy (R, Python, Scala, Java, etc.).
- Bachelor’s degree in Computer or Life Sciences or equivalent work experience
- 3 years of relevant experience in pharmaceutical industry is desired, experience in other industries in Data Engineering role will also be considered
- Knowledge of protocol, current clinical drug development processes preferred
- General knowledge of eDC systems
- Intermediate programming skills SAS, SQL or other languages R, Python, etc.
- Working knowledge of SDTM including Define.xml, CDASH, metadata preferred
- Ability to work with cross-functional team interpreting data requirements.
- Project management skills is a plus.
- Excellent written and verbal communication skills
- Aptitude and motivation learn new technologies and make appropriate recommendations for consideration is preferred.
- Vendor management oversight experience a plus
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Switzerland-Allschwil, Belgium-Antwerp-Beerse
Janssen Biologics (7266)