Job Information
Medtronic Sr. Principal Statistician - Hybrid, Mounds View, MN in Mounds View, Minnesota
Careers That Change Lives
In this exciting role as a Sr. Principal Statistician, you will have primary focus responsibility for leading statistical aspects of study design and data analysis from research clinical studies conducted for concept feasibility. This includes designing studies, calculating sample size and power, writing statistical portions of protocols and statistical analysis plans, reviewing study protocols and case report forms, analyzing and interpreting data, and preparing relevant sections of regulatory submissions, reports, and manuscripts.
Additionally, as a critical member of the Research and Technology team, you will collaborate with scientists and engineers to generate clinical evidence by testing hypotheses using both internal device collected data and external clinical data.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners because we believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Cardiac Rhythm Management (CRM):
Cardiac Rhythm Management (CRM) focuses on developing and delivering innovative solutions for diagnosing, treating, and managing heart rhythm disorders and heart failure. CRM offers a range of products and software that help patients live longer and healthier lives.
This role is hybrid in-person, located in Mounds View, MN. Travel up to 10% (primarily domestic and may have some international travel) is required for this role.
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 biological 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.
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, please ensure the minimum requirements are evident on your resume):
- Bachelor’s Degree with 10+ years of work experience in Engineering OR Advanced degree in Engineering or technical field with 8+ years of statistical experience in clinical trial design and data analysis within healthcare
Nice to Have
Master’s degree or PHD degree in Biostatistics, or Statistics and minimum 10 years of statistics experience within medical device industry or pharmaceutical industries
Experience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industries
Strong 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 strategies
Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package
Participation in FDA, PMDA or other regulatory meetings, especially panel preparation and presentation
Experience 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 execution
High degree of expertise regarding research data management
High 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/documents
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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America). 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) 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. Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.
Min Salary
168000
Max Salary
253000
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.