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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Johnson & Johnson Innovative Medicine is recruiting a Senior Principal Scientist for R&D Data Science and Digital Health Real-World Evidence

Prefered Location: Raritan / Titusville NJ; Cambridge MA; or Spring House PA. May consider remote work.

Johnson & Johnson Innovative Medicine develops treatments that improve the health of people worldwide. Research and development areas encompass oncology cardiovascular and metabolic disorders immunology pulmonary hypertension retinal disorders and neuroscience. Our goal is to help people live longer healthier lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market from patients to practitioners and from clinics to hospitals. To learn more about Janssen one of the Pharmaceutical Companies of Johnson & Johnson visit Data Science Real-World Evidence Analytics & Insights team within Johnson and Johnson Innovative Medicines develops innovative insights and solutions bringing to bear a variety of different data sources across multiple disease areas. We are looking for outstanding scientist and leader whose responsibilities include:

• Be a hands-on technical leader leading a portfolio of RWE projects while instituting best practices and developing common technical tools crafting a data-driven culture of accelerating scaling and productionalizing deliverables while mentoring and educating peers in the adoption of technical best practices and common tools.

• End-to-end expertise in RWE studies including conceptualizing the research questions data feasibility study design analysis programming and interpretation.

• Provide thought leadership and hand-on programming expertise for developing adapting and delivering Real-World Data (RWD) methodologies to mitigate observed and unobserved bias and confounding in the execution of comparative effectiveness analyses time-to-event analyses external control arm studies hybrid control arm studies retrospective and prospective study designs.

• Provide thought leadership and hand-on programming expertise to generating RWE or secondary evidence from post-hoc RCT analyses observational databases and literature reviews to support regulatory agency interactions.

• Independently create study protocols statistical analysis plans and statistical programming deliverables including analysis-ready data tables and figures using appropriate statistical analysis software while instituting best practices for execution across the broader team.

• Experience creating pipelines functions packages to perform frequently used actions and/or deliverables across broad group of stakeholders.

• Partner with the Data Science Therapeutic Area scientists to conceptualize lead shape and deliver Real World Evidence and advanced analytics solutions and insights for prioritized use cases taking ownership of one or more disease area evidence generation teams.

• Partner closely with R&D DSDH Real-World Evidence LT team to drive strategic and business planning to take a leading role in facilitating cross-functional operational initiatives ensuring effective coordination and seamless execution to drive the overall success of Real-World Evidence projects.

• Contribute to the development and implementation of best practices process improvements and innovative approaches that will further enhance the impact of the Real-World Evidence team.

• Contribute to the development and implementation of RW data strategy by identifying and exploring new opportunities for data-driven innovation to support business objectives.

• Partner with the Data Science stakeholders to lead and coordinate policy efforts to influence the regulatory acceptability of RWE in decision making.

Required qualifications:

• A Ph.D. degree or masters degree in a quantitative field (e.g. epidemiology statistics biostatistics or similar)

• At least 5 years of relevant experience within start-up technology biopharma or healthcare industries or highly relevant academic experience on a case-by-case basis

• Extensive hands-on experience with data engineering and exploratory data analysis statistical modeling time-to-event analyses comparative effectiveness analyses causal inference methods to mitigate observed and residual confounding (e.g. propensity score matching/weighting instrumental variables state transition models)

• Demonstrated expertise with multiple real-world data sources (EHR insurance claims registry data). Familiarity with data structure and programming of clinical trial data

• Excellent interpersonal communication and presentation skills

• Extensive experience with database programming and use of statistical programming languages including expert proficiency in either R or Python working proficiency in SAS and SQL

• Demonstrated experience as a technical lead in developing testing and maintaining technical frameworks for RWE analyses

• Extensive knowledge of RWE Common Data Models (OMOP FHIR i2b2) & Analysis frameworks (OHDSI pharmaverse)

• Demonstrated experience in managing operations with strong stakeholder management capabilities.

• Demonstrated experience in business planning resource allocation and 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 communicating and responding to agency reviews and comments.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federalstateor local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contactAskGSto be directed to your accommodation resource.

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