We anticipate the application window for this opening will close on - 18 Jul 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

For over a decade Medtronic has been at the forefront of transforming stroke care leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device developmentwe actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together we are changing the way stroke is managed worldwide making a lasting difference for the millions of patients affected every day.

Join a diverse team of innovators who bring their worldview their unique backgrounds and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Responsibilitiesmay 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.
• 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 to the clinicians/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 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 if required.
• 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 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 of policies and procedures for process improvements and standardization for the department and the statistics group.
• 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 Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare ORAdvanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcare

Nice to Have (Preferred Qualifications):

• Masters degree or PHD degree in Biostatistics or Statistics and minimum 8 years of statistics experience within medical device industryor pharmaceutical industries
• Experience as a biostatistician in clinical studies from the design through approval stages in the medical deviceor pharmaceutical industries
• Strong applied statistical skills includingsurvival analysis regression modelingadaptive trial designsgroup sequential methods longitudinal analysis (including mixed models) interim analysis Bayesian methods missing data strategies and multiple testing strategies
• Advanced knowledge of and/or experience withstatistical programming packages including SAS R or another statistical analysis package
• Participation inFDA PMDA or otherregulatory meetings especially panel preparation and presentation
• Experience inGood Clinical Practice (GCP)and/or regulatory compliance guidelines for clinical trialsand medical devices ( 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

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):$118400.00 - $177600.00

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.