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Senior/Principal Statistician

Abiomed Inc.

This is a Full-time position in Danvers, IL posted February 20, 2021.

n n nn 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, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,500 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.

nn nn Patients First | Innovation | Winning Culture | Heart Recovery n nn nn Abiomed is a pioneer and global leader in healthcare technology and innovation.

From the world’s first total replacement heart to the world’s smallest heart pump, Abiomed is dedicated to finding ways to bring the most advanced and beneficial technology to patients and physicians.

Our mission is to Recover Hearts and Save Lives, and we are committed to continuous research through the entire translational spectrum, from basic science to large scale randomized controlled clinical trials.

nn nn We are looking for a Senior/Principal Statistician to join our growing department of Statistics.

Reporting to the Director of Statistics, the Senior/Principal Statistician will provide statistical expertise in the design, analysis, and interpretation of clinical trial programs, regulatory submission and filings; and the generation of evidence to support publication and product commercialization.

The Senior/Principal Statistician will play a leadership role in multi-disciplinary project and study teams and will also interact closely with various steering committees for Abiomed sponsored prospective randomized studies and registries.

nn nn Responsibilities: nn Contribute to the strategic and statistical thinking in relevant product and study teams Develop trial design options and provide guidance and leadership for on-going and planned clinical studies Participate in planning, design, development, and execution of clinical trial protocols Develop statistical sections of clinical study documents, including but not limited to clinical study report, statistical analysis plan (SAP), and study synopsis/protocol Evaluate data quality, perform statistical edit checks of source data Produce and validate statistical analyses and outputs according to SAP Lead and support data analyses to enable generation of clinical manuscripts Perform quality control and validation of peer statistician’s work Provide validation and review services for internal and external projects.

Write up and communicate findings as necessary Maintain archives of study data and relevant programming documentation Lead and assist the development of internal guidelines and Standard Operating Procedures Conduct statistical simulations for evaluating and developing novel clinical trial designs Prepare project updates for weekly/monthly status meetings Maintain up to date knowledge of statistical methodology and relevant regulatory guidance nn Qualifications: nn PhD or MS in Statistics, Biostatistics, Mathematics or similar area Minimum of 5 years of clinical research experience in medical device, pharmaceutical, biotech and/or CRO industries Extensive experience in clinical trial design, data analysis and interpretation, as well as regulatory interaction and/or submission Proficient in major statistical programming languages such as SAS and R Adequate knowledge in Database Management Ability to work collaboratively with others in a team environment Possess excellent interpersonal skill Strong oral and written communication skill nn 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.

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