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Principal Clinical Data Standards - Statistics.

Employer
Johnson & Johnson
Location
Spring House, Pennsylvania, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Academic / Research
Field
Conservation science
Discipline
Statistics
Salary Type
Salary
Employment Type
Full time
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Clinical Data Standards - Statistics. 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 - Statistics role is an exciting opportunity for an experienced clinical trial statistician to leverage their expertise across Janssen clinical trials. This individual will partner with cross-functional stakeholders and develop standard statistical analysis requirements to be used in study Statistical Analysis Plans and Data Presentation Specifications that will improve the consistency, quality, compliance, and value of clinical trial information. Serve as the point of contact for clinical, statistics, and medical writing stakeholders in activities pertaining to Analysis Standards, including the development and maintenance of requirements for a data lifecycle plan (a targeted collection of integrated end-to-end standards suitable for a specific clinical program or trial design). Focus on the analysis planning and reporting components of standards, particularly those related to Statistics and Decision Sciences deliverables, but will also have a strong understanding of the full scope of end-to-end standards, including interrelationships, dependencies, and common elements.

Principal Responsibilities
  • Data lifecycle plan development and maintenance:
  • With other Clinical Data Standard (CDS) functions, define the process for the development, governance, and maintenance of the integrated, end-to-end Data Lifecycle Plan (DLP).
  • With Data Collection Standards Experts, drives the development of requirements for the DLP with cross-functional Subject Matter Experts (SMEs). Work with Regulatory Intelligence to ensure alignment with the Study Data Standardization Plan.
  • Communicate analysis requirements to and works with Integrated Standards and Analytics to create the pre-configured standards package. Perform general review for quality, completeness, and consistency with requirements.
  • Coordinate review and acceptance of DLP by functional SMEs.
  • Upon receipt of change requests or feedback from users, facilitate review, impact assessment, and resolution by standards staff and SMEs.
  • Facilitate periodic review of the DLP by cross-functional SMEs to ensure alignment with evolving science and business needs approximately annually and/or as compounds progress through their development lifecycle.
  • 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.
  • With Data Collection Standards Experts, facilitates the development of standards content requirements with cross-functional SMEs to address portfolio needs and/or gaps identified during the development of the DLP. Help SMEs understand and align with Janssen business rules, relevant industry standards and/or regulatory guidance. The Principal, Clinical Data Standards - Statistics is specifically responsible for working with Statistics and Data Analysis SMEs to ensure clear analysis plan requirements are documented (ie, content typically recorded in the protocol, SAP, and DPS).
  • Communicates requirements to the Clinical Analysis Standards Expert for Programming and Integrated Standards and Analytics to ensure that requirements and definitions are complete and clear.
  • Coordinates the scientific review and acceptance by Statistics SMEs of standard SAS code test output produced by Integrated Standards and Analytics.
  • Upon receipt of change requests or feedback from users, facilitate review, impact assessment, and resolution by standards staff and SMEs.
  • 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 DLP, how to implement standards in specific trial deliverables (eg, protocol, SAP, and DPS documents).
  • Partners with functional SMEs to drive the study-level use of the DLP 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 Development 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:
  • dentify and act on opportunities to improve or streamline processes or technologies related to standards development, implementation, or adoption.
  • Industry standards and regulatory guidance:
  • Develop and maintain expertise in relevant industry standards (e.g., protocol, ADaM, controlled terminology).
  • Participate in industry standards development directly (e.g., CDISC, TransCelerate, or PHUSE work groups) or via opportunities for review and comment. Participate in regional forums. Share knowledge with colleagues.
  • In partnership with Regulatory Intelligence, train stakeholders in industry standards fundamentals and regulatory guidance.

Qualifications
  • A minimum of a Master's degree in Science, Statistics, Mathematics or a related discipline is required. A PhD is preferred.
  • A minimum of 8 years of relevant experience in study design, analysis, interpretation, and reporting in a clinical trial environment within the pharmaceutical industry or contract research organization (CRO) with a Master's degree or a minimum of 6 years of relevant experience in study design, analysis, interpretation, and reporting in a clinical trial environment within the pharmaceutical industry or contract research organization (CRO) with a PhD is required.
  • Knowledge of the principles and practices of statistical analysis is required.
  • Experience in SAS programming is required.
  • Knowledge of relevant regulatory requirements related to analysis and reporting (e.g. Good Clinical Practices (GCP), International Conference on Harmonization (ICH)) is required.
  • Working knowledge of industry standards (e.g. CDISC, ADaM, SDTM) 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-Belgium-Antwerp-Beerse, 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-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105933386W
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