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

Senior Statistician Surgical

In this exciting role asSenior 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 calculating 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.

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 clinical research and development projects that establish the conditions essential for determining safety efficacy and marketability of medical device products.

• Uses sound statistical methodology to conduct studies relating to the life cycle of the product.

• In development-phase projects prepares the statistical component of protocols which meet project objectives health authority guidelines and clinical trial methodology standards.

• 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 and/or statistical programmers

• Supports the regulatory review and approval of the experimental therapies.

• May partner in trial design and in establishing standards for clinical conduct and the collection management and/or reporting of data.

• 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.

• Identifies potential threats to study credibility and validity and works with study team to prevent track and manage potential problems.

• Writes the statistical analysis plan for the study.

• Performs statistical analysis using statistical programming software (e.g. SAS R etc.)

• Validates and provides clear documentation of analysis programs.

• Writes Results and Methods sections of reports and manuscripts as needed.

• Consults with other (e.g. non-clinical) staff on statistical and analysis issues.

• Attends and contributes to project and department meetings.

• Demonstrates excellent collaboration and interpersonal skills.

Must Have: Minimum Requirements

• Bachelors degree with4years of statistics experience

OR

• An advanced degree with2years of statistics experience

Nice to Have

• Masters degree or PhD in biostatistics or statistics

• Experience in analysis of data from clinical studies and design of clinical trials

• Strong applied statistical skills includingsurvival analysisregression modeling Bayesian methodsadaptive trial designsgroup sequential methods longitudinal analysis (including mixed models) interim analysis missing data strategies and multiple testing strategies.

• Experience with adaptive designs

• Advanced knowledge of and/or experience withstatistical programming packages including SAS R or another statistical analysis package.

• Experience communicating complex statistical/machine learning results to technical and non-technical through journal publications conferences presentations/posters and seminars

• High level of knowledge of clinical trial methods and execution.

• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trialsand medical devices (e.g. ISO MDD/MDR).

• Prior experience in FDA and/or global regulatory submissions.

• Demonstrated ability to communicate technical content to non-statisticians (written and verbal).

• Demonstration of good oral and written communication skills

• Well-developed interpersonal skills and collaborations with multiple functions

• Demonstration or evidence of leadership competencies.

• Strong attention to detail

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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

Physical Job Requirements

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)

Compensation

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 benefitshere.

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6here.

The provided base salary range is used nationally (except in certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experiencecertification/education market conditions location etc.

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.

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