Principal Biostatistician

Principal StatisticianCareers 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 95,000 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.A Day in the LifePeripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects.The preferred location for this role is Mounds View, MNIn this exciting role as a Principal Statistician, you will have primary focus responsibility for statistical aspects of study design and analysis of data from complex 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 protocols and statistical analysis plans, review of protocol and case report forms, analysis including statistical programming 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.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.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 trial 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 properly assessed. 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.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 for process improvements and standardization for the department and the statistics group.Attends and contributes to project and department meetings.Demonstrates excellent collaboration and interpersonal skills.Must Have (Minimum Requirements):Bachelor's degreeMinimum of 7 years of statistical experience in clinical trial design and data analysis within healthcareAdvanced degree with a minimum of 5 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 and RParticipation 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/documentsFor 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 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.U.S. Work Authorization & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In 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.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io .Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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