As a Principal Clinical Insights Analyst, your responsibilities will include:
Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, etc.
Participate in the optimization of user management, content management, performance management and lifecycle management related to reporting and metrics in alignment with the direction set by the IDAR team as appropriate.
Contribute to the platform development facilitating Medical Monitoring Data Quality Management, Risk Based Monitoring, Integrated Reporting and Metrics to Maximize value for GD.
Work with business owners to develop and deliver reports and metrics such as, but not limited to:
Medical Monitoring visualizations (via iDARTS or RTDLM or future platforms)
Medical safety review, analytical risk-based monitoring, data review and cleaning, biomarker, home health care and specialty requests for decision making. (IDAR ONLY)
Measure Key Performance and Risk Indicators for clinical development organization to provide metrics, trends, and insight.
Ad hoc reporting and providing external reports as assigned.
Participate in creating reports aligned with C&SP stakeholder and business needs.
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
More than 6 years’ experience as a Business Analyst, working within Data warehouse platforms in a regulated industry OR mutually agreed based upon desired competencies
Mentoring of lower-level flex team members
Knowledge of SDTM data structure and CDISC standards (for IDAR)
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
