Janssen Scientific Affairs, LLC, is recruiting for a Senior Director, Real World Evidence (RWE) Methods Leader to be located in Titusville, NJ but may consider other Janssen location such as Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Scientific Affairs, LLC, is committed to transforming patient and population health through scientific evidence across the Janssen pharmaceutical companies.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Senior Director, Real World Evidence Methods Leader, will lead the vision, strategy development and, through matrix-based team leadership of cross-functional experts, execution of internal capabilities around the use of methods with real-world data analyses to help increase the quality and credibility of our research. These analyses include observational studies addressing economic and outcomes research questions and for designing and reporting randomized pragmatic clinical trials.
The Methods Leader responsibilities include taking a leadership role in methods reviews of RWE studies at Janssen, largely focusing on research to address the needs of payers across the Americas Region.
The successful candidate will serve as the lead reviewer and, through matrix-based team leadership, manage cross-functional expert methods reviewers.
Successful partnership will be required across Janssen groups such as RWE, Health Economics and Outcomes Research, Epidemiology, Biostatistics, Medical Affairs, Market Access, Scientific Operations, IT and others to:
• Identify and share best practices regarding methods of RWE studies
• Identify strategies for new types of methodologies and opportunities where new methodologies could better leverage RWD assets for use with payers and regulatory authorities
• Further expand the internal knowledge and capacity to use evolving methodologies in RWE studies, using various training approaches and best practice sharing
• Ensure scientifically and methodologically rigorous analyses are used for observational studies addressing economic and outcomes research questions
• Participate in the design and reporting of randomized pragmatic clinical trials and other prospective studies that leverage observational data
• Contribute to refining governance processes and contributing to local and global standards in methodologies.
• This individual will also maintain strong relationships with external partners including academic health economics and statistics experts, data (claims, EHRs, registries) and analytics experts, technology platform experts and other key external stakeholders.
This individual will also:
• Work closely with the RWE Team Leaders, RWE Alliance Leaders, HECOR Team Leaders and the RWE Design and Analytics Group on real world data and RWE strategies and initiatives.
• Lead and manage a highly functioning review board of cross functional members.
• Participate in the authorship of publications and presentations together with other Janssen researchers and external partners, particularly around methods development.
• Participate in external advisory and/or methods standards groups, e.g., those sponsored by universities, research institutions and professional organizations
• Assist in the development of overarching real world data strategies, including advancing and assessing methodological approaches for RWE analytics from observational data
• A Doctorate degree in a quantitative field, such as econometrics, epidemiology or statistics is required. Experience in econometrics is preferred.
• A minimum of 12 years of related experience is required.
• Expertise as a methodologist for observational studies (prospective and retrospective) from design through conduct, analysis and reporting required.
• Expertise with a broad range of economic, statistical, clinical trial and epidemiological research methods required.
• Experience leading highly-functioning statistical and/or analytical experts in a direct-reporting or matrixed-reporting manner required.
• Expertise working with claims databases and electronic medical (health) records required.
• Significant prior publication track record in clinical, statistical and/or health economic journals required.
• Experience interacting with academia, health systems and/or payers required.
• Experience with programming in major statistical analysis systems, such as SAS and R preferred.
• Experience working on randomized pragmatic trials preferred.
• Firm understanding of the uses of evidence-based medicine and comparative effectiveness analyses for health policy decision-making preferred.
• Management of statistical activities of external service providers preferred.
• Experience interacting with drug regulatory authorities preferred.
• Excellent communication and training skills required.
• Experience working in multiple therapeutic areas preferred
• Travel up to 20% of the time.
United States-New Jersey-Titusville
Janssen Scientific Affairs, LLC (6120)
Health Economics R&D
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