We anticipate the application window for this opening will close on - 3 Jan 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as Principal Statistician, you will be responsible for providing strategic leadership on the design and analysis of scientific data including, but not limited to, clinical studies and research experiments. Represents Medtronic from a statistical perspective with customers and regulatory bodies.  Develops relevant code for data extraction, independently or in collaboration with a programmer, for reporting and analysis purposes according to Medtronic internal requirements. This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts. Work will generally be self-directed.


Location: Boulder, CO or Mounds View, MN (hybrid)

Responsibilities may include the following and other duties may be assigned.

• • Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of medical device products. 
  • Uses sound statistical methodology to conduct studies relating to the life cycle of the product. 

  • Prepares the statistical component of protocols which meet project objectives, regulatory guidelines, international standards, and clinical trial methodology standards. 

  • Develops and applies statistical theories, methods, and software. 

  • Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. 

  • Provides specifications and directions to the clinicians/statistical programmers 

  • Supports the regulatory review and approval of the experimental therapies. 

  • Partners in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. 

  • Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met.  This requires calculation of sample size and power, as well as determination of appropriate design assumptions from published literature. 

  • Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems. 

  • Writes the statistical analysis plan for the study. Also writes and validates error-checking requirements for the study data. 

  • Performs statistical analysis using statistical programming software (e.g., SAS, R etc.) 

  • Takes a leadership role in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory agencies regarding study design and interpretation, as well as in response to journal reviewer feedback. 

  • Validates and provides clear documentation of analysis programs. 

  • Writes Results and Methods sections of reports and manuscripts as needed and supports Discussion sections.