Senior Statistician

Medtronic Job OpportunityAt 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 LifeFor 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 development—we 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. It's no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.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 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 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, 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 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 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.Bachelor's degree Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare OR Advanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcareNice to Have (Preferred Qualifications):Master's degree or PHD degree in Biostatistics, or Statistics and minimum 8 years of statistics experience within medical device industry or pharmaceutical industriesExperience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industriesStrong 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 strategiesAdvanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis packageParticipation in FDA, PMDA or other regulatory meetings, especially panel preparation and presentationExperience 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 executionHigh degree of expertise regarding research data managementHigh 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/documentsPhysical Job RequirementsThe 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 & CompensationMedtronic 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): $118,400.00 - $177,600.00 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 insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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), and Capital 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 plansAbout MedtronicWe 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