J&J Family of Companies
Manager, Epidemiology and Real-World Data Sciences MedTech Surgery
J&J Family of Companies, New Brunswick, New Jersey, United States, 08901
Manager, Epidemiology and Real-World Data Sciences
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. 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. OR Master'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
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. 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. OR Master'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