We anticipate the application window for this opening will close on - 1 Aug 2025

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

A Day in the Life

In this exciting role as a Statistician in the Cardiac Surgery Operating Unit you will provide statistical support for clinical studies to satisfy applicable regulatory standards and Medtronic internal requirements. You will have primary focus responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval publications or marketing 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 study reports and manuscripts. Work will generally be self-directed but will be reviewed by the Manager at key time points.

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. Were 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.

Location: Mounds View MN
Ability to travel up to 10% (primarily domestic).

Role and responsibilities

• Participate in the development of study protocols including refinement of the study objectives and endpoints to establish safety and efficacy. Has responsibility for study design including statistical hypotheses and sample size estimation; and data analysis plan. Prepares the statistical component of protocols which meet project objectives health authority guidelines and clinical trial methodology standards.
• Writes Statistical Analysis Plans (SAP) for studies. Also writes error-checking requirements for the study data.
• Participate in the design of Case Report Forms (CRF) to assure adequate and appropriate collection of clinical study data to meet study objectives.
• Provide statistical support for regulatory submissions including data analysis (including the documentation of statistical methods analyses and results) and presentation interpretation of results and report writing.
• Provide statistical support for marketing and physician requests; including study design and data analysis (including the documentation of statistical methods analyses results and interpretation of results) for abstracts presentations and manuscripts. Writes Results and Methods sections of reports and manuscripts as needed.
• Develop statistical programs for data analysis and report generation. Validate and document validation of statistical programs.
• Identify potential threats to study credibility and validity; work with study teams to prevent and manage potential problems.
• Assist the study team in responses to regulatory authorities.
• Participate in the development and improvement of the database systems including specifications for the database design to assure the availability and quality of the clinical study data.
• 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.
• Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
• Attends and contributes to project and department meetings.

Must Have (Minimum Requirements):
To be considered for this role the minimum requirements must be evident on your resume.

• Bachelors degree in Biostatistics or Statistics
• Minimum of 2 years of statistical experience in clinical trial design and/or data analysis within healthcare or related areas including:
  • Applied statistical skills
  • Design and analysis of data from clinical studies
  • Statistical programming and the use of statistical analysis packages (SAS R)
• Masters degree in Biostatistics or Statistics with 0 years of experience

Nice to Have (Preferred Qualifications):

• Masters or PhD degree in Biostatistics or Statistics.
• More than 1 year of experience as a biostatistician in clinical studies from the design through approval stages in the medical heath research organizations or medical device or pharmaceutical industries
• Knowledge of relational databases
• Good oral and written communication skills
• Good interpersonal skills
• Strong applied statistical skills including survival analysis regression modeling Bayesian methods adaptive trial designs group sequential methods longitudinal analysis (including mixed models) interim analysis missing data strategies and multiple testing strategies
• Advanced knowledge of and/or experience with statistical programming packages including SAS and R
• High degree of expertise in research data management
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
• Experience writing or updating clinical reports/documents

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):$88800.00 - $133200.00

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. 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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-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:

Medtronic benefits and compensation plans

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 95000 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 here.

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.