Senior Principal Scientist, R&D Real-World Evidence (RWE) Advance Analytics (AA)

Role Summary

Senior Principal Scientist, R&D Data Science and Digital Health, Real-World Evidence at Johnson & Johnson Innovative Medicine. Lead a portfolio of RWE projects, develop methodologies, and drive strategic real-world evidence initiatives to support regulatory interactions and decision making.

Responsibilities

• Be a hands-on technical leader, leading a portfolio of RWE projects while instituting best practices, developing common technical tools, and mentoring peers.
• End-to-end expertise in RWE studies including conceptualizing research questions, data feasibility, study design, analysis, programming, and interpretation.
• Provide thought leadership and hands-on programming for RWD methodologies to mitigate bias and confounding in comparative analyses and various study designs.
• Generate RWE or secondary evidence from post-hoc analyses, observational databases, and literature reviews to support regulatory interactions.
• Independently create study protocols, statistical analysis plans, and programming deliverables including analysis-ready data, tables, and figures.
• Develop pipelines, functions, and packages to perform common actions across stakeholders.
• Partner with Data Science Therapeutic Area scientists to conceptualize and deliver Real World Evidence and advanced analytics solutions for prioritized use cases.
• Collaborate with R&D Real-World Evidence LT to drive strategic planning and cross-functional coordination for project success.
• Contribute to best practices, process improvements, and innovative approaches to enhance Real-World Evidence impact.
• Contribute to RW data strategy by identifying opportunities for data-driven innovation.
• Lead and coordinate policy efforts to influence regulatory acceptability of RWE in decision making.

Qualifications

• A Ph.D. or master‚Äôs degree in a quantitative field (e.g., epidemiology, statistics, biostatistics, or similar)
• At least 5 years of relevant experience in start-up, technology, biopharma, healthcare, or relevant academic settings
• Hands-on experience with data engineering, exploratory data analysis, statistical modeling, time-to-event analyses, comparative effectiveness analyses, and causal inference methods
• Experience with multiple real-world data sources (EHR, claims, registries); familiarity with clinical trial data
• Excellent interpersonal, communication, and presentation skills
• Proficiency in R or Python, with working proficiency in SAS and SQL
• Experience as a technical lead in developing, testing, and maintaining frameworks for RWE analyses
• Knowledge of RWE Common Data Models (OMOP, FHIR, i2b2) and analysis frameworks (OHDSI, pharmaverse)
• Experience in operations management with stakeholder management and in business planning/resource prioritization

Preferred Qualifications

• Familiarity with drug discovery and the clinical development process
• Expertise in Oncology, Immunology, or Neuroscience drug development
• Experience in regulatory-grade evidence and responding to agency reviews

Skills

• Advanced Analytics, Data Analysis, Data Visualization, Mentorship
• Strategic Thinking, Technical Credibility, Data Quality, Data Privacy
• Critical Thinking, Data Reporting, Data Savvy, Econometric Models