Senior Principal, R&D Data Science and Digital Health, Real-World Evidence (RWE) Statistics

About the position At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at Johnson & Johnson Innovative Medicine is recruiting for Senior Principal, R&D Data Science and Digital Health, Real-World Evidence (RWE) Statistics Preferred location: Titusville, NJ ; Sping House, PA ; San Diego, CA or Cambridge, MA. Remote work considered on a case by case basis 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 The Real-world Evidence & Advanced Analytics team within Johnson and Johnson Innovative Medicines is looking for outstanding scientists and leaders whose responsibilities include: Responsibilities • Be a hands-on scientific and technical leader, leading a portfolio of RWE projects, developing best practices, and mentoring team members. • Identify common technical requirements for RWE projects, develop and maintain a common suite of tools that enable RWE data scientists to accelerate project delivery. • 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 expertise for developing and applying Real-World Data (“RWD”) methodologies to mitigate observed and unobserved biases in the execution of external control arm studies, hybrid control studies, comparative effectiveness analyses, etc. • Provide 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 create study protocols, statistical analysis plans, and statistical programming deliverables including analysis-ready data, tables and figures • Partner with the Data Science Therapeutic Area scientists to conceptualize, lead, shape and deliver Real World Evidence Requirements • 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 Nice-to-haves • 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. Benefits • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). • This position is eligible to participate in the Company’s long-term incentive program. • Employees are eligible for the following time off benefits: – Vacation – up to 120 hours per calendar year – Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year – Holiday pay, including Floating Holidays – up to 13 days per calendar year – Work, Personal and Family Time - up to 40 hours per calendar year Apply tot his job