Prin Statistician

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

In this exciting role as Principal 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.

Careers That Change Lives

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.

Operating Unit

Our Surgical OU is one new powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. Well approach the market with a unified approach from concept single strategy capitalize on our global commercial capabilities and prove the power of our combined portfolio.

With the Medtronic Mission as our North Star we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.

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 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.
• Develops and/or applies 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.
• May 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.
• 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.)
• 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.
• 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.
• Leads development of policies and procedures for the department and the statistics group.
• Mentors and trains Statisticians and/or Senior Statisticians in their job duties and responsibilities.
• Attends and contributes to project and department meetings.

Must Have (Minimum Requirements):

• Bachelors degree required with a minimum of 7 years of statistics (i.e. biostatistics data analysis) experience or advanced degree with a minimum of 5 years of statistics (i.e. biostatistics data analysis) experience

Nice to Have (Preferred Qualifications):

• Masters degree or PhD in Biostatistics Statistics or equivalent
• 7 years of post-graduate statistical experience
• 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.
• Participation in FDA regulatory meetings especially panel preparation and presentation Experience writing or updating clinical reports/documents.
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal).

For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

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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):$146400.00 - $219600.00

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

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.

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 findhere 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.