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Director of Statistics

Date: 
Location: 

Danvers, MA, US

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 1,400 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
 

 

Reporting to the Sr. Director of Clinical Operations and Translational Research, the Director of Statistics will oversee and lead the company’s statistical department through its work across the various domains of our clinical development, including trial design, data analyses for regulatory submissions and scientific publications, and will play a leadership role in multi-disciplinary project and study teams. The Director of Statistics will have close interaction with the various steering committees of Abiomed’s sponsored prospective randomized studies and registries.

 

The leader in this position will oversee the construct, analyses, management and documentation of complicated data sets and research projects; review statistical output; interpret and explain results; provide input into study reports and abstracts/manuscripts while ensuring completeness and accuracy and, importantly, manage & mentor the growing statistics department’s team.

 

Principle Duties and Responsibilities:

  • Responsible for leading, mentoring and developing the Department of Statistics
  • Manage, oversee all the relevant aspects, with regard to statistical analyses and planning, of Abiomed’s clinical trials, observational studies, real-world practice research and internal analyses needs
  • Oversee the development of clinical study reports and publication deliverables, including the programming of analysis data sets and creation of tables and figures.
  • Responsible for assigned projects and the performance of all Biostatistics staff working on the project(s), including effective team operation and cross-functional collaboration
  • Contribute to external interactions with regulators, payers, review boards
  • Lead implementation of innovative designs and analysis methods at the study or project level
  • Perform quality control checks of advanced SAS code and output produced by other Statistical Programmers
  • Provide validation and review services for internal and external projects. Write up and communicate findings as necessary
  • Prepare statistical sections of clinical documentation, including but not limited to clinical study reports, statistical analysis plans, protocols, etc.
  • Responsible for developing and maintaining organization of all data files, archiving and data storage for straightforward retrieval of research data
  • Provide guidance and leadership for the development and maintenance of current and future databases
  • Cooperate in further development of internal guidelines and SOPs
  • Prepare project updates for weekly/monthly status meetings
  • Maintain up to date knowledge of statistical concepts, methods and techniques

 

Job Qualifications:

  • PhD in Biostatistics or Mathematics, and >10 years of relevant work experience
  • Proficient in SAS statistical programming and other Microsoft Windows applications.
  • Minimum of >8 years of Biostatistics clinical research experience in the medical device, pharmaceutical, biotech and/or CRO industries
  • Solid experience in the design, planning and analysis of clinical trials, including the detailed and technical write-up of complex Statistical Analysis Plans
  • Knowledge in Database Management and Data Mining
  • Ability to work in a highly regulated field according to procedures, rules and SOPs
  • Problem solver, able to approach issues from a number of perspectives, summarizing data to draw a conclusion
  • Team player able to lead, motivate and develop a growing team

 

 

 

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