Principal Statistician - CRDN

Overview

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.

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 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.

Responsibilities

• 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 clear documentation of analysis programs.
• Writes Results and Methods sections of reports and manuscripts as needed and ensures interpretation of statistical and clinical findings in regulatory submissions, reports, and manuscripts accurately reflect the data collected.
• Consults with other (e.g., non-clinical) staff on statistical and analysis issues.
• Lead development for process improvements and standardization for the department and the statistics group.
• Attends and contributes to project and department meetings.
• Demonstrates excellent collaboration and interpersonal skills.

Must Have (Minimum Requirements)

To be considered for this role, the minimum requirements must be evident on your resume.

• Bachelor's degree
• Minimum of 7 years of statistical experience in clinical trial design and data analysis within healthcare
• Or advanced degree with a minimum of 5 years of statistical experience in clinical trial design and data analysis within healthcare

Nice to Have (Preferred Qualifications)

• Master’s degree or PHD degree in Biostatistics, or Statistics and minimum 8 years of statistics experience within the medical device industry or pharmaceutical industries
• Experience as a biostatistician in clinical studies from design through approval stages in the medical device or pharmaceutical industries
• Strong applied statistical skills, including survival analysis, regression modeling, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, missing data strategies and multiple testing strategies
• Advanced SAS programming skills, and experience with other statistical programming packages, including R.
• Participation in FDA, PMDA or other regulatory meetings, especially panel preparation and presentation
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR)
• High level of knowledge of clinical trial methods and execution
• High degree of expertise regarding research data management
• High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel)
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
• Experience writing or updating clinical reports/documents

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday.

It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. Salary ranges for U.S (excl. PR) locations (USD): $143,200.00 - $214,800.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Regular employees are those who are not temporary. The following benefits and compensation plans are available to regular employees: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Tuition assistance/reimbursement, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement, and Capital Accumulation Plan. Some benefits may vary by location.

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About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.

We are committed to diversity and equal employment opportunity (EEO). We may provide reasonable accommodations for qualified individuals with disabilities. See full policy details in the notices below.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP).

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. For details, see the Los Angeles County or California Fair Chance ordinances noted in the job posting.

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