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Company | Abiomed |
Address | Danvers, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-06-22 |
Posted at | 1 year ago |
Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives . With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
- 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 protocol development, revisions, submission, and approval, including collaboration with study steering committee and principal investigators and communication with FDA
- Support generation of scientific content for trial-related documents, including annual and final study reports
- Ensure data analysis integrity for clinical studies within scope of role
- Provide scientific support for development of electronic data capture (EDC) for Abiomed-sponsored clinical studies
- Conduct literature review and clinical data review to support regulatory submissions and CERs
- Contribute to strong publication/presentation cadence for Abiomed-sponsored clinical studies
- 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 planning and execution of steering committee meetings and investigator/research coordinator meetings
- Support execution of the regulatory pathway required for new investigational devices and for indication expansion globally
- Cross-collaboration with other Medical Office departments
- Support the production of trial-related interim analyses, hypothesis testing, publications, and presentations
- Support execution of Abiomed’s scientific objectives within Abiomed-sponsored clinical studies
- 1-3 years lrelevant post-graduate research experience preferred
- Strong research background and publication history
- Clinical science/research experience in cardiology/cardiovascular space or medical devices preferred
- Strong work ethic, self-motivated, team player with excellent English written and oral communication skills and strong interpersonal skills
- Strong understanding of biostatistics
- Advanced degree in science or engineering; PhD or MD required
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