Senior Statistician

Medtronic•Mounds View, MN

4d•$118,400 - $177,600•Remote

About The Position

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 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 Life Peripheral 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 This role can be remote-based, located anywhere in the U.S. Preferred locations: Mounds View, MN In this exciting role as a Senior Statistician, you will be responsible for statistical aspects of study design, study execution, 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 the statistical portions of protocols and statistical analysis plans, review of protocol and case report forms, analysis, including statistical programming, 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.

Requirements

Bachelor's degree
Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare
Advanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcare
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.

Nice To Haves

Master’s degree or PHD degree in Biostatistics, or Statistics
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
Experience writing or updating clinical reports/documents
Advanced knowledge of and/or experience with statistical programming packages, including SAS and R
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)

Responsibilities

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.
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.
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.
Performs statistical analysis using statistical programming software (e.g., SAS, R etc.)
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.
Attends and contributes to project and department meetings.
Demonstrates excellent collaboration and interpersonal skills.

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)