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Principal Statistician - CRDN

Principal Statistician - CRDN

AVE Medtronic Vascular IncMinneapolis, Minnesota, United States of America
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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 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) :

  • 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.

    Physical Job Requirements

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

    A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits .

    Physical Job Requirements

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

    The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles : While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

    Benefits & Compensation

    Medtronic offers a competitive Salary and flexible Benefits Package

    A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

    Salary ranges for U.S (excl. PR) locations (USD) : $143,200.00 - $214,800.00This 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. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

    The following benefits and additional compensation are available to those regular employees who work 20+ hours per week : Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance / reimbursement, andSimple Steps (global well-being program).

    The following benefits and additional compensation are available to all regular employees : Incentive plans, 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 (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

    Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

    Further details are available at the link below :

    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. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

    Learn more about our business, mission, and our commitment to diversity .

    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. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

    If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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    Statistician • Minneapolis, Minnesota, United States of America