We anticipate the application window for this opening will close on - 8 Sep 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

Coronary and Renal Denervation therapies are a critical part of the Medtronic Cardiovascular portfolio, treating patients with complex conditions, including coronary artery disease and hypertension. We lead the way with recent FDA approved devices caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click Here

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.


This role is on-site in Mounds View, MN
Ability to travel up to 10% (primarily domestic and may have some international travel).

In this exciting role as a Principal Statistician, you will have primary responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval, publications, marketing or reimbursement purposes. This includes responsibility for design of studies, calculating 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, presentations and manuscripts.  Work will generally be self-directed but will be reviewed by the Manager at key time points. 

A Day in the Life

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 biomedical, pharmaceutical and/or biological products.
• Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
• Oversight of statistical support and deliverables for ensuring adherence to study specific requirements as well as consistent applications of relevant methods across the portfolio.
• In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Research, develop and/or applies novel 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 for statistical programmers.
• Supports the regulatory review and approval of the experimental therapies.
• Partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. 

Other responsibilities:

• 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 possible determination of appropriate design assumptions from published literature.
• Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
• Identifies potential threats to study credibility, validity, and data integrity and works with study team to prevent, track, and manage potential problems.
• Writes the statistical analysis plan for the study. 
• 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. 
• Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods.  Methods must be appropriate for the kind of data collected and required assumptions must be tested.
• Validates and provides clea