Associate Director Regulatory RWE & EPI
Scorpion Therapeutics, New Brunswick, New Jersey, us, 08933
Role Summary
Associate Director Regulatory RWE & EPI leading or contributing to RWE projects and evidence generation for regulatory submissions and approvals of J&J MedTech devices. Focus areas include label expansions and de novo approvals with global regulatory agencies, leveraging real-world data and epidemiology to support safety, effectiveness, and value demonstrations. Responsibilities
Work in close collaboration with colleagues and business partners to develop protocol-driven studies in cardiovascular, surgery, and methods development, evaluating safety, effectiveness, benefit-risk, and utilization patterns of J&J MedTech devices; include predictive analytics and disease burden assessment where applicable. Develop, review, and write study protocols and statistical analysis plans (SAP). Lead and oversee analyses; execute and review code; work with analysts to extract data, create analytical files, and perform statistical analyses per protocol. Develop, review, and write study reports for regulatory submissions (FDA label expansions and initial approvals) and regulatory authorities in the EU, Asia Pacific, and Latin America. Conduct feasibility assessments of medical device studies using in-house real-world data resources; evaluate relevance and reliability of data sources. Lead or contribute to design and data analysis of RWE studies, including comparative studies, external controls, indirect comparisons, covariate balancing, outcome analyses, systematic reviews, and meta-analyses. Lead or contribute to projects evaluating disease natural history, treatment patterns, patient journeys, safety and effectiveness using clinical and surrogate endpoints, or benefit-risk questions for specific devices. Manage research projects and timelines. Disseminate scientific information through technical reports, presentations, and peer-reviewed publications; develop manuscripts and conference abstracts/presentations. Present research to internal stakeholders or external audiences. Lead evaluation, identification and cataloging of real-world data assets; assess linked datasets to enhance data relevance and reliability for regulatory submissions. Collaborate with internal partners and cross-sector epidemiology teams. Lead or participate in work streams to standardize research and analytical processes; engage with FDA and other regulatory authorities regarding RWE studies and respond to comments on protocols and reports. Qualifications
A PhD in Biostatistics, Statistics, Epidemiology, or related fields, or an MD with a masters in Biostatistics/Statistics/Epidemiology or related fields. At least 5 years of experience in RWE and epidemiology-related research in pharma or medical device industries, consulting, or healthcare organizations. In-depth knowledge of electronic medical records, claims, and hospital billing databases. Hands-on experience with EMR, claims and/or hospital billing data databases and coding taxonomies (ICD, CPT, HCPCS); development of codelists for medical events. Experience writing study protocols and SAPs for RWE studies of medical products. Strong knowledge of epidemiologic and statistical concepts (confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses). Experience conducting comparative safety and effectiveness evaluations using propensity score methods. Hands-on experience in statistical programming (R or SAS) and database programming (SQL or Python) with large healthcare databases. Experience authoring peer-reviewed publications using real-world datasets. Experience with target trial emulation is a plus; experience with machine learning/AI modeling using large healthcare databases is preferred. Agility to work in a fast-paced, changing environment; strong written and verbal communication; strong teamwork and collaboration skills. This position may require up to 10% domestic and international travel. Skills
Advanced Analytics Clinical Operations Cross-Functional Collaboration Data Privacy Standards Developing Others Disease Management Emergency Planning Environmental Health Epidemiology Financial Competence Inclusive Leadership Industry Analysis Leadership Public Health Public Health Surveillance Researching Team Management Vendor Management Education
PhD in Biostatistics, Statistics, Epidemiology, or related field, or MD with related Master's in Biostatistics/Statistics/Epidemiology. Additional Requirements
Up to 10% travel (domestic and international) as needed.
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Associate Director Regulatory RWE & EPI leading or contributing to RWE projects and evidence generation for regulatory submissions and approvals of J&J MedTech devices. Focus areas include label expansions and de novo approvals with global regulatory agencies, leveraging real-world data and epidemiology to support safety, effectiveness, and value demonstrations. Responsibilities
Work in close collaboration with colleagues and business partners to develop protocol-driven studies in cardiovascular, surgery, and methods development, evaluating safety, effectiveness, benefit-risk, and utilization patterns of J&J MedTech devices; include predictive analytics and disease burden assessment where applicable. Develop, review, and write study protocols and statistical analysis plans (SAP). Lead and oversee analyses; execute and review code; work with analysts to extract data, create analytical files, and perform statistical analyses per protocol. Develop, review, and write study reports for regulatory submissions (FDA label expansions and initial approvals) and regulatory authorities in the EU, Asia Pacific, and Latin America. Conduct feasibility assessments of medical device studies using in-house real-world data resources; evaluate relevance and reliability of data sources. Lead or contribute to design and data analysis of RWE studies, including comparative studies, external controls, indirect comparisons, covariate balancing, outcome analyses, systematic reviews, and meta-analyses. Lead or contribute to projects evaluating disease natural history, treatment patterns, patient journeys, safety and effectiveness using clinical and surrogate endpoints, or benefit-risk questions for specific devices. Manage research projects and timelines. Disseminate scientific information through technical reports, presentations, and peer-reviewed publications; develop manuscripts and conference abstracts/presentations. Present research to internal stakeholders or external audiences. Lead evaluation, identification and cataloging of real-world data assets; assess linked datasets to enhance data relevance and reliability for regulatory submissions. Collaborate with internal partners and cross-sector epidemiology teams. Lead or participate in work streams to standardize research and analytical processes; engage with FDA and other regulatory authorities regarding RWE studies and respond to comments on protocols and reports. Qualifications
A PhD in Biostatistics, Statistics, Epidemiology, or related fields, or an MD with a masters in Biostatistics/Statistics/Epidemiology or related fields. At least 5 years of experience in RWE and epidemiology-related research in pharma or medical device industries, consulting, or healthcare organizations. In-depth knowledge of electronic medical records, claims, and hospital billing databases. Hands-on experience with EMR, claims and/or hospital billing data databases and coding taxonomies (ICD, CPT, HCPCS); development of codelists for medical events. Experience writing study protocols and SAPs for RWE studies of medical products. Strong knowledge of epidemiologic and statistical concepts (confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses). Experience conducting comparative safety and effectiveness evaluations using propensity score methods. Hands-on experience in statistical programming (R or SAS) and database programming (SQL or Python) with large healthcare databases. Experience authoring peer-reviewed publications using real-world datasets. Experience with target trial emulation is a plus; experience with machine learning/AI modeling using large healthcare databases is preferred. Agility to work in a fast-paced, changing environment; strong written and verbal communication; strong teamwork and collaboration skills. This position may require up to 10% domestic and international travel. Skills
Advanced Analytics Clinical Operations Cross-Functional Collaboration Data Privacy Standards Developing Others Disease Management Emergency Planning Environmental Health Epidemiology Financial Competence Inclusive Leadership Industry Analysis Leadership Public Health Public Health Surveillance Researching Team Management Vendor Management Education
PhD in Biostatistics, Statistics, Epidemiology, or related field, or MD with related Master's in Biostatistics/Statistics/Epidemiology. Additional Requirements
Up to 10% travel (domestic and international) as needed.
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