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Sr. Statistician /Principal Statistician

Date:  Sep 17, 2021
Location: 

Danvers, MA, US, 01923

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, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 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 Sr./Principal Statistician to join our growing department of Statistics. Reporting to the Director of Statistics, the Sr./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 Sr./Principal Statistician will play an important role in multi-disciplinary project and study teams and will also have close interaction with various steering committees for Abiomed sponsored prospective randomized studies and registries.

 

Responsibilities:

  • 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

 

Qualifications:

  • 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

 

 

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.


Nearest Major Market: Boston