Principal Statistician

We anticipate the application window for this opening will close on - 20 Apr 2026 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 Our Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses including Conduction Pacing Therapy (CPT), Cardiovascular Diagnostics & Services (CDS), and Defibrillation Solutions (DS). We also support Cardiac Ablation Solutions (CAS). Together, we will transform the lives of people with cardiac arrhythmias and heart failure. 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 position will be based in Mounds View, MN. In this exciting role as Principal Statistician , you will be responsible for statistical aspects of study design and analysis of data from clinical studies conducted for regulatory approval or marketing purposes. This includes responsibility for design of studies, calculation 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 but will be reviewed by the Manager at key time points. Role and Responsibilities: 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 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. Researches, develops and/or 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. 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. Takes a leadership role in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regul ... (truncated, view full listing at source)