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 https://www.jnj.com **Job Function:** Data Analytics & Computational Sciences **Job Sub** **Function:** Epidemiology **Job Category:** People Leader **All Job Posting Locations:** New Brunswick, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America **Job Description:** Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson MedTech Surgery is hiring a Manager, Epidemiology and Real-World Data Sciences to join our team and grow their expertise and career in using real-world evidence (RWE). The preferred location for the position is New Brunswick, NJ, Titusville NJ, or Springhouse, PA. Remote work options in the US may be considered on a case-by-case basis and if approved by the Company. The MedTech Epidemiology and Real-World Data Sciences (MT Epi-RWDS) organization within Johnson & Johnson is an industry leader, on the cutting edge of conducting observational and epidemiologic research to support post-market safety and effectiveness, regulatory submissions, product development, product launches, value assessments, predictive analytics, machine learning, and business development of medical devices. We are also applying AI tools in RWE analyses, including using AI on digital and robotic intraprocedural data linked to long-term patient outcomes. The MT Epi-RWDS team is part of the Global Epidemiology Organization in the Office of the Chief Medical Officer. **Key Responsibilities:** **General Responsibilities** + Leading or contributing to projects to evaluate disease natural history, treatment patterns, patient journeys, safety and effectiveness of devices using clinical and surrogate endpoints, or benefit-risk questions for specific devices + Developing, reviewing, and writing study protocols, statistical analysis plans (SAP), and study reports + Analyzing or overseeing the analysis of electronic healthcare databases such as EHRs, insurance claims data, hospital billing data, or registries + Managing research projects and timelines + Disseminating scientific information through technical reports, presentations, and publications in peer-reviewed literature, as agreed by the team + Presenting research to internal stakeholders or external audiences + Collaborating with partners within J&J and working closely with colleagues from MD Epi-RWDS and larger cross-sector epidemiology + Leading or participating in work streams / task forces to standardize research and analytical processes to improve efficiency and quality of deliverables + Work with analysts to extract raw data from servers, create analytical data files, and execute statistical analyses based on protocol specifications + Work with large electronic healthcare databases and clinical coding taxonomies such as the International Classification of Diseases and Current Procedural Terminology + Evaluate linked datasets to improve the relevance and reliability of real- world data sources to address important research questions **Surgery RWE Responsibilities** The Manager will be responsible for assisting with various RWE projects and evidence generation needs for the J&J MedTech Surgery business unit (previously Ethicon, Inc.). Working in close collaboration with colleagues and business partners, the candidate will have an opportunity to lead protocol-driven studies in the areas of general surgery, surgical oncology, robotics, digital solutions, and methods development; specifically, evaluating the safety, effectiveness, outcomes, and utilization patterns of devices manufactured by J&J MedTech Surgery, including biosurgery and wound closure, endomechanical, energy, robotics, digital solutions, and interventional technologies. Other areas of RWE work may include predictive analytics and quantifying the burden of diseases and surgical complications. Examples of specific activities will include preparing study protocols, leading study analysis, and developing manuscripts and conference abstracts and presentations. **Additionally, the person will also be assisting with the Regulatory team within the MT Epi-RWDS that focuses on RWE for Regulatory Approvals** : + Assisting with developing RWE studies and evidence submissions for marketing authorization approvals (label expansions and initial approvals) by the US FDA, as well as regulatory authorities in the EU, Asia Pacific and Latin America. + Supporting the design and data analysis of observational studies including the creation of external controls for single arm trials, adjusted indirect comparisons, covariate balancing, and outcome analyses + Assisting with the evaluation, identification and cataloging of real-world data assets to answer key research questions + Conducting systematic reviews and meta-analyses + Evaluate the relevance and reliability of new data sources for medical device studies, including product-specific studies of J&J devices + Supporting the writing of statistical analysis sections of reports and drafts of regulatory submission dossiers, manuscripts, and conference abstract/poster presentations. **Qualifications:** + A PhD in Biostatistics, Data Science, Epidemiology, Health Services Research, Health Outcomes Research, or other related field with at least 2 years experience of Epidemiology related research work in health care is required.ORMaster’s degree in Biostatistics, Data Science, Epidemiology, Health Services Research, Health Outcomes Research, or other related field with at least 4 years of Epidemiology or related research work experience in health care is required. + Experience writing study protocols and statistical analysis plans for RWE studies is required + Experience working with healthcare claims databases, electronic medical records and/or hospital billing data is required + Experience in statistical programming in R or SAS and database programming in SQL or Python using large healthcare datasets is preferred + Familiarity with comparative safety, effectiveness and/or economic outcomes evaluations using propensity score balancing methods is preferred + Strong knowledge in epidemiologic and statistical concepts such as confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses is required + Experience authoring peer reviewed publications (abstracts, posters, and manuscripts) using real world datasets is preferred + Knowledge in machine learning and artificial intelligence modeling is a plus + Strong written and verbal communication skills are required + Agility to work in a fast paced, changing environment is required + Strong teamwork skills and ability to collaborate well with team members are required + This position may require up to 10% of domestic and international travel 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 federal, state or 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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $115,000 to $197,800. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 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)). 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 Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. \#LI-SL \#JNJDataScience \#JNJMedTech-DS \#LI-Remote