Senior Clinical Research Scientist

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 Med Tech, 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  () .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

** Job Function:*
* Discovery & Pre-Clinical/Clinical Development

** Job Sub*
* ** Function:*
* Clinical Development & Research - Non-MD

** Job Category:*
* Scientific/Technology

** All Job Posting Locations:*
* Danvers, Massachusetts, United States of America

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* Job Description:

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* ** We are searching for the best talent for Senior Clinical Research Scientist.*
* 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 Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at  

LI-Hybrid

This is a hybrid role available in Danvers Massachusetts within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Remote work options may be considered on a case-by-case basis and if approved by the Company.

** Responsibilities:*
* + Support execution of Abiomed's scientific objectives within Abiomed-sponsored clinical studies

+ Support protocol development, revisions, submission, and approval, including collaboration with study steering committee and principal investigators and communication with FDA

+ Work closely with biostatistics team to evaluate study design options and analyze study data to support decisions related to protocol development and study execution

+ Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations

+ Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies

+ Support planning and execution of steering committee meetings and investigator/research coordinator meetings

+ Support generation of scientific content for study-related documents, including annual and final study reports

+ Review periodic study reports for outliers, ranges, and potentially problematic data; identify and communicate root causes and suggest possible solutions, document data observations, and follow pre-established processes and procedures

+ Support execution of the regulatory pathway required for new investigational devices and for indication expansion globally

+ Ensure data analysis integrity for clinical studies within scope of role

+ Contribute to strong publication/presentation cadence for Abiomed-sponsored clinical studies

+ Conduct literature review and clinical data review to support regulatory submissions and CERs

+ Cross-collaboration with Medical Office and other departments

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* Qualifications:

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* + Advanced degree in science or engineering; MS, PhD or MD required

+ At least 3 years relevant post-graduate research experience

+ Clinical science/research experience in cardiology/cardiovascular space or medical devices preferred

+ Strong research background and publication history

+ Strong understanding of biostatistics

+ Proficient in statistical programming…