Principal, ADaM Metadata Standard Development.

Job content

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com

Principal Clinical Data Standards - ADaM Metadata

• Takes a leadership role in partnering with cross-functional stakeholders to drive and facilitate the development and utilization of standards to improve the efficiency of clinical research analysis and reporting processes and improve the consistency, quality, compliance, and value of clinical trial information.
• Leads the development and maintenance of 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).
• Supports the functions adopting the standards in clinical trials, in close collaboration with other Clinical Data Standards (CDS) colleagues and ensures that team members understand the value of clinical standards and are trained on their use.
• Ensures adoption, conformance, and compliance metrics are evaluated with appropriate action taken.
• Develops deep expertise in industry standards related to Study Data Tabulation Model (SDTM), Controlled Terminologies (CT), ADaM and Therapeutic Area User Guides (TAUG).
• Focuses 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.
  
  

Principal Responsibilities

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.
• Partners 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) standards.
• Responsible for the 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. The job holder is responsible for the mapping and derivation of metadata used for automating the data flow from SDTM to ADaM. Responsible for documenting, implementing and maintaining scientifically and operationally correct traceability between domain and variable metadata across the different metadata models. The job holder is responsible for setting up the standard metadata compliant to the industry standards and health authority regulations.
• Coordinates 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.
• 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 will guarantee formal change management control and versioning of the standards is applied and adhered to and the job holder governs formally all the changes to ADaM metadata standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
• The job holder is responsible for input to the Methodology & 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 (eg, ADaM design, analysis dataset creation).
• Partners 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 adoption.
  
  

Industry standards and regulatory guidance

• Develop and maintain expertise in relevant industry standards (eg, ADaM, SDTM, controlled terminology, define.xml) and regulatory guidance.
• Participate in industry standards development directly (eg, CDISC, TransCelerate, or PHUSE work groups) or via opportunities for review and comment. Participate in regional forums. Share knowledge with colleagues.
  
  

In The Role Of ADaM Standards Therapeutic Area Lead

• Specific job responsibilities described above will be focused within the TA:
• Responsible for the preconfiguration of the ADaM metadata standards in line with the disease area needs within the TA, while maintaining the traceability and lineage of the data. This includes identification of global standard variants that are applicable to the TA/DA, along with the development of the disease specific standard ADaM metadata. The job holder is responsible for documenting and managing correctly the lineage between master standards and the many preconfigured standards.
• Responsible for the scientific correctness of the metadata, and consults 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.
• Point of contact for the statistical programming team within the TA on adopting and implementing the TA/DA ADaM metadata standards in the studies (internally or outsourced to a CRO). The job holder will use adoption and conformance metrics to identify potential improvements in the adoption of ADaM metadata standards in the studies to maximize the value of standards.
• Responsible to acquire/maintain strong expertise and understanding of the disease area analysis requirements, including related industry standards and regulatory requirements, within the Therapeutic area.
  
  

In The Role Of ADaM Standards Global Lead

• Specific job responsibilities described above will be applicable at the Global Level, across TAs:
• Responsible for the development and management of the ADaM metadata standards for global analysis needs applicable across TAs, while maintaining the traceability and lineage of the data. Global analysis needs refers to standards that are applicable to more than one TA and have been promoted to the global level (eg, demographics, disposition, exposure, routine safety reporting), along with the management/maintenance of all global variants.
• Responsible for the scientific correctness of the global metadata, and consults 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.
• Responsible for working with the ADaM Standards Therapeutic Area Leads to ensure consistency of ADaM standards for global topics across TA/DA and partnering in the change request process to evaluate impact and scientific appropriateness.
• Responsible to acquire and maintain deep expertise in industry standards related to Study Data Tabulation Model (SDTM), Controlled Terminologies (CT), Analysis Data Models (ADaM) and Therapeutic Area User Guides (TAUG).
  
  

Responsibility For Others

This position reports to the Head of Clinical Analysis Standards. This position has no permanent direct reports but may lead project teams, mentor junior staff, and supervise consultants supporting clinical analysis standards deliverables. This position executes work independently and proactively recommends and defines activities necessary to fulfill the mission of the standards organization. Status of work is self-managed and discussed at major milestones with the Head of Clinical Analysis Standards and within the Clinical Data Standards team where issues impacting timelines, quality, resources, and/or budget are discussed. This position may also be accountable to another IDAR, GD, or QS leaders based on cross-functional leadership assignments.

May supervise consultants or co-ops.

Principal Relationships

Contacts in theorganization:

• Clinical Data Standards - all levels
• Quantitative Sciences: Statistics and Decision Sciences - functional leaders, clinical team statistical leads, and trial statisticians at all levels; similar roles in Clinical Pharmacology.
• Statistical Programming & Analysis: Functional Leaders, programming leads, and programmers at all levels.
• Data Management: Functional Leaders, data management leads, and data managers at all levels
• Regulatory Medical Writing: Functional leaders and medical writers at all levels.
• Therapeutics Area: disease area leaders, clinical development team leaders, study physicians, clinical scientists.
• Other contacts include Patient Reported Outcomes, External Alliances, EBIS, IT.
  
  

Contacts Outside The Organization

• CDISC and other industry organizations involved in the development of standards such as TransCelerate Biopharma and PHUSE.
  
  

Qualifications

• Bachelor’s degree in a scientific discipline required. Advanced degree (Master’s, PhD or equivalent) preferred.
• Minimum of 8 years relevant experience programming and analysing scientific data in a pharmaceutical/clinical trial environment, with 2 years of experience implementing clinical data standards required. Experience in a range of therapeutic areas preferred.
• In-depth knowledge of the principles and practices (including tools and processes) of clinical research analysis and reporting is required. Proficiency in SAS programming is required; Experience in R, SpotFire, and other programming packages in statistical computing environments is preferred.
• Expert knowledge of relevant industry standards (e.g. CDISC ADaM, SDTM) and regulatory requirements (eg, GCP, ICH) related to reporting and data submission is required.
• Working knowledge of medical concepts sufficient to support a broad range of disciplines is required.
  
  

Primary Location

United States-New Jersey-Titusville-1125 Trenton Harbourton Road

Other Locations

United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Switzerland-Allschwil, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105933384W