Principal Clinical Data Standards - ADaM Metadata

Contenuto del lavoro

Janssen Research & Development, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Principal 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 information. The Principal Clinical Data Standards - ADaM Metadata will take 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. This individual will lead 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). Support 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. Ensure adoption, conformance and compliance metrics are evaluated with appropriate action taken. Develop deep 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. Principal Responsibilities: Clinical analysis standards development and maintenance: With other CDS functions, define 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) standards. 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. Oversee the maintenance of the metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio. 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. 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 adoption. Industry standards and regulatory guidance: Develop and maintain expertise in relevant industry standards (e.g. ADaM, SDTM, controlled terminology, define.xml) and regulatory guidance. 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 with colleagues. Qualifications A minimum of a Bachelor’s degree in a Scientific discipline is required. Advanced degree (Master’s, PhD) preferred. A minimum of 8 years of relevant experience programming and analyzing scientific data in a clinical trial environment within the pharmaceutical industry or contract research organization (CRO) is required. Experience implementing clinical data standards is required. Knowledge of the principles and practices (including tools and processes) of clinical research analysis and reporting is required. 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 Hypertension. Must have excellent communication and interpersonal skills. Must have strong problemsolving and issue resolution skills. 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 of disability. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2105970112W