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Janssen Research and
Development, a member of Johnson and Johnson Family of Companies, is recruiting
for a Principle Technical Data Architect, Data Engineering to be located in Raritan,
NJ or Springhouse, PA or Titusville, NJ or any J&J locations within the
targeted area. 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. And we pursue
the most promising science, wherever it might be found. Janssen Research
& Development, LLC discovers and develops innovative medical solutions to
address important unmet medical needs in oncology, immunology, neuroscience,
infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Please visit http://www.JanssenRnD.com for more information. We are Janssen. Our
mission drives us. Our patients inspire us. We collaborate with the world for
the health of everyone in it.Thriving on a diverse
company culture, celebrating the uniqueness of our employees and committed to
inclusion. Proud to be an equal
opportunity employer.Exciting opportunity
to be part of new and growing technical data management team contributing to
our next generation data strategy driving effectiveness and efficiency of
clinical trials from collection to submission.The development of
best-in-industry Data Science capabilities is critical to our ambition to be
most innovative healthcare company.
Combining various data streams and providing data near real-time data
and visualizations are key component to obtaining our ambitions. The position is
primarily accountable for providing expertise, delivery and oversight of
technical clinical data management activities from data stream integrations to
submission-ready tabulation packages. This position will
also take on the role of Therapeutic Area Partner (TAP) which provides end to
end operational leadership, strong analytical and problem-solving skills,
technical insight and expertise within a given TA/disease area. 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. Review and create specifications for mapping data models to
be used for quality review and for final data model (SDTM or other). 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. 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.).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 ·
Ability
to work with cross-functional team interpreting data requirements·
Expert
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 experienceJohnson
& Johnson is an Affirmative Action and Equal Opportunity Employer. All
qualified applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity, age,
national origin, or protected veteran status and will not be discriminated
against on the basis of disability.Primary LocationUnited States-New Jersey-Raritan-Other LocationsNorth America-United States-Pennsylvania-PhiladelphiaOrganizationJanssen Research & Development, LLC (6084)Job FunctionClinical Data ManagementRequisition ID1143190801