Associate Director Regulatory RWE & EPI

Johnson & Johnson Innovative Medicine•New Brunswick, NJ

1d•$137,000 - $235,750

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 https://www.jnj.com Caring for the world, one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science, bringing innovative ideas, products, and services to advance the health and well-being of people, on a global basis. We thrive on and grow with an inclusive company culture, follow the ethics-based Credo of Johnson & Johnson, and are an equal opportunity employer. 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 regulatory submissions, post-market safety and effectiveness evaluations, product development, value assessments, predictive analytics, machine learning, and business development of medical devices. Johnson and Johnson MedTech is approximately the second largest medical device company in the world (it may vary over time), with a strong focus in cardiovascular, surgery and robotic devices, and vision. The MT Epi-RWDS team is part of the Global Epidemiology Organization in the Office of the Chief Medical Officer and collaborates with the Johnson & Johnson Innovative Medicines Epidemiology group. The team leads Real-World Data innovation and methodological excellence across Johnson & Johnson’s Medical Device sector and provides skills and expertise in using RWE to support label expansions, product development, safety, value demonstration for payers, and other activities. We are looking for a talented and innovative individual to join our team and grow their expertise and career in using RWE for regulatory submissions and approvals of innovative medical technology. The person will be responsible for leading or contributing to various RWE projects and evidence generation needs for J&J MedTech business units. We are hiring an individual to join our team and grow their expertise and career in using real-world evidence (RWE) for global marketing authorization approvals (label expansions and de novo approvals) for J&J MedTech devices with the US FDA, the Chinese NMPA, the EU notified bodies, and other national regulatory agencies. The preferred location for the position is New Brunswick, NJ, Titusville, NJ, Springhouse, PA, Irvine, CA and Jacksonville, FL. Other J&J locations will be considered on case to case basis.

Requirements

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 of RWE and Epidemiology related research work in the pharmaceutical or medical device industry, consulting, or healthcare organizations
In-depth knowledge of the structure and caveats of electronic medical records, claims, and/or hospital billing databases
At least 5 years of hands-on experience working with electronic medical records, claims databases, and/or hospital billing data databases and clinical coding taxonomies such as the International Classification of Diseases (ICD), Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), including the development of the codelists for medical events
At least 5 years of experience in writing study protocols and statistical analysis plans for RWE studies of medical products
Strong knowledge and expertise in epidemiologic and statistical concepts such as confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses
At least 5 years of experience conducting comparative safety and effectiveness outcomes evaluations using propensity score methods
At least 5 years of hands-on experience in statistical programming in R or SAS and database programming in SQL or Python using large healthcare databases
At least 5 years of experience authoring peer-reviewed publications (abstracts, posters, and manuscripts) using real world datasets
Agility to work in a fast paced, changing environment
Strong written and verbal communication skills
Strong teamwork skills and ability to collaborate well with team members

Nice To Haves

Hands-on experience with the target trial emulation method including statistical programming is a plus
Experience in machine learning and AI programming and modeling using large healthcare databases for research work experience is preferred.

Responsibilities

Work in close collaboration with colleagues and business partners to develop protocol-driven studies in the areas of cardiovascular, surgery, and methods development, evaluating safety, effectiveness, benefit-risk assessment, and utilization patterns of medical devices manufactured by J&J MedTech in these areas. Other areas of RWE work may include predictive analytics and quantifying the burden of diseases and surgical complications.
Develop, review, and write study protocols and statistical analysis plans (SAP)
Lead and oversee the analysis; execute and/or review codes for analyses; and work with analysts to extract raw data from servers, create analytical data files, and execute statistical analyses based on protocol specifications
Develop, review, and write study reports for regulatory 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
Conduct feasibility assessments of medical device studies using in-house real-world data resources, including electronic medical records, administrative healthcare claims databases, hospital billing data, or registries and clinical coding taxonomies such as the International Classification of Diseases (ICD), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) and evaluate the relevance and reliability of real-world data sources
Lead or contribute to the design and data analysis of RWE studies including comparative studies, the creation of external controls for single-arm trials, adjusted indirect comparisons, covariate balancing, and outcome analyses, as well as systematic reviews and meta-analyses
Lead or contribute to projects to evaluate disease natural history, treatment patterns, patient journeys, safety and effectiveness of medical devices 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 publications in peer-reviewed literature, as agreed by the team
Develop, review, and write RWE study manuscripts and conference abstracts and presentations
Present research to internal stakeholders or external audiences
Lead the evaluation, identification and cataloging of real-world data assets to answer novel research questions
Evaluate linked datasets to improve the relevance and reliability of real-world data sources to address important research questions for regulatory submissions
Collaborate with partners within J&J and work closely with colleagues from MD Epi-RWDS and larger cross-sector epidemiology
Lead or participate in work streams / task forces to standardize research and analytical processes to improve efficiency and quality of deliverables
Participate in discussions with the FDA and other regulatory authorities regarding RWE studies such as Q-submissions, and address the comments on RWE study protocols and reports

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)).
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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