Associate Director Regulatory RWE & EPI

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.