Associate Director, Clinical Data Standards - Statistics Neu
The Associate Director, Clinical Data Standards - Statistics takes a leadership role in providing operational expertise in developing and managing analysis standards for clinical research. The Associate Director, Clinical Data Standards - Statistics role partners with Integrated Data and Reporting (IDAR) and Quantitative Sciences (QS) to govern end-to-end (E2E) clinical data and analysis standards.
Position is open to Raritan, NJ,Titusville, NJ, Spring House, PA, Switzerland, The UK, or Beerse, Belgium.
The role of the Associate Director is to lead a partnership with business stakeholders to align standards with business needs, provide expert standards guidance to content subject matter experts (SMEs) developing or updating standards content including ensuring compliance with relevant regulatory guidance, support users in implementation of the standards, and support and align with relevant industry standards. The Associate Director for Biostatistics will focus on the analysis planning components of standards but will also have a strong understanding of the full scope of E2E standards, including interrelationships, dependencies, and common elements.
- Leads a team of standards associates in addressing the following key responsibilities:
- Align standards with business needs
- Ensure that agreements with functional representatives describing what the standards are and how they will be used are documented and communicated.
- Lead functional representatives in defining business requirements for standards content and format, how standards will be assessed for quality and compliance with those internal requirements and relevant regulatory guidance and industry standards, and what metrics can be used to assess standards usage and value.
- Maintain documentation describing requirements (e.g., conventions, templates, instructions, quality and compliance checks).
Work with functional representatives to define how standards will be accessed and used from the standards library and develop the mechanism to collect metrics. Provide training and communications related to standards.
Provide expert standards guidance: Responsible for ensuring that content SMEs have adequate guidance to develop deliverables that are consistent with standards business requirements. Train content SMEs on standards principles, business requirements, and concepts of end-to-end traceability and interoperability. Guide SMEs in developing project scope and/or evaluation of change requests.
Guide SMEs in development and review of standards deliverables. Help SMEs understand and align with relevant industry standards and/or regulatory guidance. Perform general review of standards deliverables for quality and compliance. Ensure that final standards content is loaded in the standards library.
Support implementation: Provide general training, communications, and documentation for standards implementation for internal and external users. Address general questions and coordinate with content SMEs for topic-specific questions and implementation support. Gather and evaluate user feedback.
Support industry standards: Develop and maintain expertise in relevant industry standards and regulatory requirements. Participate in industry standards development directly (e.g., CDISC, TransCelerate, PHUSE) or via opportunities for review and comment. Provide communications and training to internal users and partners. If applicable, lead internal standards user group.
- Master’s degree in Statistics or related field at least 10 years of experience or PhD in Statistics or related field at least 8 years of experience is required
- A minimum of 4 years of experience managing a team of statisticians is preferred.
- Strong understanding of the principles and practices of clinical research analysis and reporting is required
- Basic knowledge of SAS programming is required
- Strong knowledge of relevant industry standards and regulatory requirement is preferred.
- Excellent English verbal and written communication skills is required
- Leadership experience working in a team environment with strong collaboration and problem-solving skills is required
- Able to manage diverse viewpoints and drive issues to resolution is preferred
- Ability to prioritize tasks and work effectively in a fast-paced multi-project environment is preferred
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Switzerland, United Kingdom, United States-New Jersey-Raritan, United States-Pennsylvania-Spring House, Belgium-Antwerp-Beerse
Janssen Research & Development, LLC (6084)