Senior Principal Scientist, Data Science RWE

About the role

The Real-world Evidence & Advanced Analytics team within Johnson & Johnson Innovative Medicines is seeking a hands-on scientific and technical leader to join our team. This role includes:

• Leading a portfolio of Real-World Evidence (RWE) projects, developing best practices, and mentoring team members.
• Identifying common technical requirements for RWE projects and maintaining a common suite of tools to accelerate project delivery.
• End-to-end expertise in RWE studies, including conceptualizing research questions, data feasibility, study design, analysis, programming, and interpretation.
• Providing thought leadership and hands-on programming expertise for developing and applying RWD methodologies to mitigate biases in external control arm studies, hybrid control studies, comparative effectiveness analyses, etc.
• Providing thought leadership and hands-on programming expertise to generate actionable insights from post-hoc RCT analyses, observational databases, and literature reviews to support regulatory agency interactions.
• Independently creating study protocols, statistical analysis plans, and statistical programming deliverables, including analysis-ready data, tables, and figures.
• Partnering with Data Science Therapeutic Area scientists to conceptualize, lead, shape, and deliver Real World Evidence.

Responsibilities

Key responsibilities include:

• Developing and maintaining a common suite of tools to accelerate project delivery.
• End-to-end expertise in RWE studies, including conceptualizing research questions, data feasibility, study design, analysis, programming, and interpretation.
• Providing thought leadership and hands-on programming expertise for developing and applying RWD methodologies to mitigate biases in external control arm studies, hybrid control studies, comparative effectiveness analyses, etc.
• Generating actionable insights from post-hoc RCT analyses, observational databases, and literature reviews to support regulatory agency interactions.
• Creating study protocols, statistical analysis plans, and statistical programming deliverables, including analysis-ready data, tables, and figures.
• Partnering with Data Science Therapeutic Area scientists to conceptualize, lead, shape, and deliver Real World Evidence.

Requirements

Qualifications include:

• A Ph.D. degree in epidemiology or biostatistics.
• Expert coding skills using R, Python, or SAS.
• At least 5 years of relevant experience within biopharma companies, RWE consulting firms, or other relevant healthcare industries.
• Extensive hands-on experience with data extraction, cleaning, and analysis, as well as statistical methods to mitigate confounding and selection biases.
• Expertise with multiple real-world data sources (EHR, insurance claims, registry data).
• Familiarity with clinical trial data structure.
• Excellent interpersonal, communication, and presentation skills.

Preferred Qualifications

• Familiarity with drug discovery and the clinical development process.
• Subject matter knowledge in oncology, Immunology, or Neuroscience.
• Experience in regulatory-grade evidence, communicating, and responding to agency reviews and comments.