Job Information
Medtronic Principal Statistician in Mounds View, Minnesota
Principal Statistician – Surgical
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. Work will generally be self-directed but will be reviewed by the Manager at key time points.
Location: Mounds View, MN preferred; open to remote within the U.S., minimal amounts of travel as required
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. 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.
Operating Unit
Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. We’ll 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.
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 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
- Bachelor’s degree with a minimum of 7 years of statistics (i.e., biostatistics, data analysis) experience
OR
- An advanced degree with a minimum of 5 years of statistics (i.e., biostatistics, data analysis) experience
Nice to Have
Master's 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, including survival analysis, regression modeling, Bayesian methods, adaptive trial designs, group 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 with statistical 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 trials and 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).
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. Let’s 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, recruiter 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 benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .
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 experience, certification/education, market conditions, location, etc.
Min Salary
139200
Max Salary
208800
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.