Principal, Clinical Data Standards - Statistics.

Job content

Janssen Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. Please visit https://www.janssen.com/research-and-development for more information.

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 diseases of our time. And we pursue the most promising science, wherever it might be found!

We are Janssen. Our mission drives us. Our patients inspire us. Our CREDO guides us: https://www.jnj.com/credo. We collaborate with the world for the health of everyone in it. Bring your talents to our mission!

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, we are proud to be an equal opportunity employer.

The Principal, Clinical Data Standards Statistics is an exciting opportunity for an experienced clinical trial statistician to leverage their expertise across Janssen clinical trials. Partnering with cross-functional stakeholders, the Principal, Clinical Data Standards - Statistics will 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. The job holder serves 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. The job holder will 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 CDS functions, defines 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 SMEs. Works with Regulatory Intelligence to ensure alignment with the Study Data Standardization Plan.
• Communicates analysis requirements to and works with Integrated Standards and Analytics to create the pre-configured standards package. Performs general review for quality, completeness, and consistency with requirements.
• Coordinates 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.
• Facilitates 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:

• Identify 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.

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 Development 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 leader based on cross-functional leadership assignments.
• May supervise consultants or co-ops.

Principal Relationships

Contacts in the organization:

• Clinical Development 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.
• DDA: Functional Leaders, Data Analysis Leads, Data Delivery Leads, Operations Functional Leads, programming leads, data management leads, and programmers 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.
• Partners such as CROs.

Qualifications

• Master’s degree with 10+ or PhD with 8+ years relevant experience in study design, analysis, interpretation, and reporting in a pharmaceutical/clinical trial environment. University/college degree in statistics or a related field is required.
• In-depth knowledge of the principles and practices of statistical analysis is required. Proficiency in SAS programming is required.
• Expert knowledge of relevant regulatory requirements related to analysis and reporting (eg, GCP, ICH) and working knowledge of industry standards (eg, ADaM) is required.
• Working knowledge of medical concepts sufficient to support a broad range of disciplines is required. Experience in a range of therapeutic areas is preferred.
• Excellent English written, oral, and interpersonal communication skills are required. Experience acting as a change agent or trainer is preferred.
• Leadership experience working in a cross-functional team environment with strong collaboration, facilitation, and problem-solving skills is required. Must be able to manage diverse viewpoints and drive issues to resolution. Able to prioritize tasks and work effectively in a fast-paced, multi-project, matrixed environment.

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Allschwil, United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2105912385W