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Principal Technical Data Architect

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Job Description


Clinical Data Management: Principle 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 expertise, 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.   

 

This is a leadership position which will also take on a Therapeutic Area Partner (TAP) role which provides end to end operational leadership, strong analytical and problem-solving skills, technical insight and expertise within a given TA/disease area. This position may be responsible for the management and development of staff.  Also responsible for contributing to our automation and innovation efforts.  

 

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.

 

Therapeutic Area Partner (TAP) responsibilities include; helping to drive operational excellence as a leader within the TA.  Understanding of portfolio demand and ensuring appropriate resources planned and available to support demands.  Helps build and strengthen partnerships, community of practice as a leader within the therapeutic area of responsibility.  May provide supervisory support to staff, including coaching, mentoring, training, career development, priority setting, etc.

 

Develop and maintain working knowledge and expertise in programming languages utilized in clinical data management (SAS, SQL, etc.) and apply continuous learning as part of next generation data strategy (R, Python, Scala, Java, etc.).

 



Qualifications
Qualifications
·  Bachelor’s degree in Computer or Life Sciences or equivalent work experience is required; Master’s degree preferred
·   7 years of relevant experience in pharmaceutical industry is desired, experience in other industries in Data Engineering role will also be considered 
·  In-depth knowledge of protocol, current clinical drug development processes preferred
·  Expert knowledge of eDC systems 
·  Expert programming skills SAS, SQL or other languages R, Python, etc. 
·  Expert knowledge of SDTM including Define.xml, CDASH, metadata preferred
·  Experience in resource and standards compliance management preferred 
·  Team leadership and people development practices preferred. 
·  Ability to work with cross-functional team interpreting data requirements
·  Strong project management skills and knowledge of team management principles are required
·  Excellent written and verbal communication skills
·  Proven knowledge of good data management practices
·  Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is preferred
·         Vendor management oversight experience

Primary Location
Belgium-Antwerp-Beerse-
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Switzerland-Allschwil
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
2005803120W