Head Clinical Analysis Standards
- Clinical analysis standards development, maintenance, implementation and compliance.
- Development and maintenance of clinical analysis standards for use in clinical trials.
- Assessments and statistical endpoints, statistical methods, ADaM metadata, displays used in the clinical study report, and related SAS macros.
- Be expert on industry standards (e.g. CDISC) related to the clinical data and analysis standards and evaluate new industry standards for applicability and fit with the requirements of the Janssen R&D drug development programs.
- Be an expert on regulations (e.g. FDA, EMA) pertaining to the requirements for submitting clinical trial data to regulatory authorities (e.g. FDA will require CDISC compliance by December 2016).
- Ensuring that standards are structured and governed in a manner that is well aligned with stakeholder processes in order to maximize efficiencies and value.
- Scientific fit and ensuring that these standards have incorporated the best available medical knowledge. Ensure that clinical analysis standards comply with relevant industry standards and regulations.
- Develop and maintain plans for implementing the clinical analysis standards in clinical trials based on the best scientific fit and operational efficiencies the standards can bring to the drug development processes.
- Coach and provide guidance to Clinical Team representatives and leaders responsible for programming deliverables across one or more Clinical Teams.
- Drive the implementation of clinical analysis standards with our partners such as Clinical Research Organizations (CROs), Central Labs, etc.
- Focus on continuous improvement.
- Manage a dashboard with relevant clinical analysis standards compliance metrics, evaluate trends, identify systemic compliance issues and risks in clinical trial and define and propose solutions to eliminate the compliance issues and significantly reduce compliance risks.
- Contribute to a continuous improvement and innovation culture with respect to the current and future data standards and related infrastructure to optimize the user experience across Global Development and with internal and external partners.
- Create an Internal and External Benchmark.
- Establishing an internal and external benchmarking network facilitating the distillation of best practices from leading organizations externally whilst also identifying best practices from internal teams within J&J.
- Be a member of industry standards organizations such as CDISC and PHUSE and work with industry experts to leverage and exchange knowledge and experience on regulations (e.g. FDA, EMA) pertaining to the requirements for submitting clinical trial data to regulatory authorities (e.g. FDA will require CDISC compliance by December 2016).
- Membership on the IDAR Clinical Development Leadership Team.
- Contribute to overall data standards strategy and the successful execution of annual goals and objectives of the data standards group.
- Provide regular updates and insights to the data standards and IDAR leadership team of the status of clinical analysis data standard initiatives, highlighting operational or scientific roadblocks and proposing potential solutions that will assist in removing the roadblocks.
- Bachelor’s degree or higher in statistics, mathematics, computer science or other scientific fields required.
- 10 or more years’ of experience in clinical research in a biopharmaceutical or CRO environment required.
- Experience in personnel management required.
- Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Strong understanding of the principles and practices of clinical research analysis and reporting.
- Working knowledge of medical concepts sufficient to support a broad range of disciplines.
- Strong knowledge of relevant industry standards and regulatory requirements.
- Project management leadership experience, including making decisions and solving challenging issues is required.
- Leadership experience with strong collaboration and problem-solving skills. Able to manage diverse viewpoints and drive issues to resolution.
- Ability to prioritize tasks and work effectively in a fast-paced multi-project environment.
For more information please contact me at: +31 (0)20 20 44 502 or email@example.com.