Lead Clinical Data Standards - ADaM Metadata.
Company: Johnson & Johnson
Posted on: January 15, 2022
Janssen Research & Development, LLC, a member of Johnson &
Johnson's Family of Companies, is recruiting for a Lead Clinical
Data Standards - ADaM Metadata. This position can be located in
Titusville, NJ; Raritan, NJ; Spring House, PA; Beerse, Belgium;
High Wycombe, United Kingdom; Leiden, Netherlands; or Basel,
Switzerland. Remote locations within North America (East and
Midwest Regions) and Europe may be considered.
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, cardiovascular and metabolism, and pulmonary
hypertension. Please visit http://www.JanssenRnD.com for more
The Lead Clinical Data Standards - ADaM Metadata will define and
maintain Analysis Data Models (ADaM) Metadata for global and
disease area analysis standards/Data Lifecycle Plans (DLPs)
supporting the data flow from data delivery to data analysis and
reporting, with input from cross-functional subject matter experts
(SMEs). This individual will support the functions adopting the
standards in clinical trials, in close collaboration with other
Clinical Data Standards (CDS) colleagues and ensure that team
members understand the value of clinical standards and are trained
on their use. Ensure adoption, conformance, and compliance metrics
are evaluated with appropriate action taken. Develop strong
expertise in industry standards related to Study Data Tabulation
Model (SDTM), Controlled Terminologies (CT), ADaM and Therapeutic
Area User Guides (TAUG). Focus on analysis planning and reporting
components of standards, particularly those related to data
analysis deliverables, but will also have a strong understanding of
the full scope of end-to-end standards, including
inter-relationships, dependencies, and common elements.
- Clinical analysis standards development and maintenance:
- With other CDS functions, defines the process for the
development, governance, and maintenance of the integrated,
end-to-end standards content/DLP.
- Partner across CDS functions to facilitate the development of
standards content requirements with cross-functional SMEs to
address portfolio needs and/or gaps identified during the
development of the disease area or therapeutic area (TA)
- Definition and maintenance of standard clinical data analysis
and results metadata for use in clinical trials, translating the
standard statistical requirements into standard ADaM Metadata.
Mapping and derivation of metadata used for automating the data
flow from SDTM to ADaM. Document, implement and maintain
scientifically and operationally correct traceability between
domain and variable metadata across the different metadata models.
Set up the standard metadata compliant to the industry standards
and health authority regulations.
- Coordinate the scientific review and acceptance by Statistical
Programming and Analysis SMEs of standard ADaM Metadata to ensure
they are consistent with requirements and fit for purpose.
- Upon receipt of change requests or feedback from users,
facilitate review, impact assessment and resolution by standards
staff and SMEs.
- Provide input to the Methodology and Innovation group of
Statistical Programming on the design, development, and maintenance
of standard code supporting the data flow from data delivery (SDTM)
to study report.
- Drive standards adoption:
- Partner with functional SMEs to provide training to internal
and external users on standards principles and concepts such as
end-to-end traceability and interoperability, topic-specific
standards, how to use the global/disease area (DLP) standards, how
to implement standards in specific trial deliverables (e.g. ADaM
design, analysis, dataset creation).
- Partner with functional SMEs to drive the study-level use of
global/disease area (DLP) standards to ensure optimal adoption of
and conformance to standards.
- Address questions and coordinate with content SMEs for
topic-specific questions and implementation support.
- Partner with Clinical Data Standards and business functions to
define meaningful metrics assessing standards adoption,
conformance, regulatory compliance, and value.
- Evaluate metrics reports, review with CDS, functional SMEs and
management, identify and take action as needed to increase the
value of standards to the organization.
- Continuous improvement:
- Identify and act on opportunities to improve or streamline
processes related to standards development, implementation, or
- Industry standards and regulatory guidance:
- Develop and maintain expertise in relevant industry standards
(e.g. ADaM, SDTM, controlled terminology, define.xml) and
- Participate in industry standards development directly (e.g.
CDISC, TransCelerate, PHUSE work groups) or via opportunities for
review and comment. Participate in regional forums. Share knowledge
- In partnership with regulatory experts, train stakeholders in
industry standards fundamentals and regulatory guidance.
- A minimum of a Bachelor's degree in a Scientific discipline is
required. Advanced degree (Master's, PhD) preferred.
- A minimum of 6 years of relevant experience programming and
analyzing scientific data in a clinical trial environment within
the pharmaceutical industry or contract research organization (CRO)
- Experience implementing clinical data standards is
- Knowledge of the principles and practices (including tools and
processes) of clinical research analysis and reporting is
- Experience in SAS programming is required.
- Experience in R, SpotFire, and other programming packages
within statistical computing environments is preferred.
- Working knowledge of industry standards (e.g. CDISC, ADaM,
SDTM) is required.
- Knowledge of relevant regulatory requirements related to
reporting and data submission (e.g. Good Clinical Practices (GCP),
International Conference on Harmonization (ICH)) is required.
- Project management skills required.
- Experience in the following Therapeutic Areas preferred:
Oncology, Immunology, Infectious Diseases and Vaccines,
Neuroscience, Cardiovascular and Metabolism, Pulmonary
- Must have excellent communication and interpersonal
- Must have strong problemsolving and issue resolution
- Must have strong leadership skills.
- The ability to collaborate effectively with all levels of
management in a fastpaced, matrixed environment is required.
- This position will require up to 10% travel.
Johnson & 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
United States-New Jersey-Titusville-1125 Trenton Harbourton
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North
America-United States-Pennsylvania-Spring House, Europe/Middle
East/Africa-United Kingdom-England-High Wycombe, Europe/Middle
East/Africa-Belgium-Antwerp-Beerse, North America-United States-New
Janssen Research & Development, LLC (6084)
Keywords: Johnson & Johnson, Trenton , Lead Clinical Data Standards - ADaM Metadata., Healthcare , Titusville, New Jersey
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