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.

Patients First | Innovation | Winning Culture | Heart Recovery

We are looking for a strong clinical scientist to support the development and design of Abiomed’s global clinical studies with the focus on sound clinical evidence generation to drive better patient outcomes with the use of Abiomed products. The Senior/Clinical Research Scientist will provide scientific support for clinical studies within the Clinical and Regulatory Affairs department, including trial design, development, and execution. The ideal candidate will be able to directly influence a strong evidence generation engine for Abiomed products. This role provides opportunity to further develop into a scientific leader within the clinical research domain.

Primary Duties and 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 trial-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 other Medical Office departments

Job Qualifications:

• Advanced degree in science or engineering; PhD or MD required
• 1-3 years lrelevant post-graduate research experience preferred
• Clinical science/research experience in cardiology/cardiovascular space or medical devices preferred
• Strong research background and publication history
• Strong understanding of biostatistics
• Strong work ethic, self-motivated, team player with excellent English written and oral communication skills and strong interpersonal skills

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.