Principal Statistician

Medtronic

. Design, plan, and execute biostatistical components of research and development projects for medical device products .

Posted 10/12/2026full-timeUnited StatesMid-LevelSenior💰 $146,400 - $219,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics and data analysis, with a strong focus on clinical trial design, statistical methodology, and regulatory compliance. Proficient in statistical programming using SAS and R, with the ability to communicate complex statistical concepts effectively to diverse audiences.

Highest-signal resume keywords

BiostatisticsStatistical Programming (SAS, R)Clinical Trial DesignRegulatory Compliance (GCP, ISO, MDD/MDR)Statistical Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Survival AnalysisRegression ModelingBayesian MethodsAdaptive Trial DesignsLongitudinal AnalysisInterim AnalysisMissing Data StrategiesMultiple Testing StrategiesStatistical Analysis PlansData Interpretation

Soft Skills

CommunicationMentoringCollaborationProblem-SolvingTraining

Industry Keywords

Good Clinical Practice (GCP)FDA Regulatory SubmissionsClinical Trial MethodologyStatistical Analysis SoftwareRegulatory Agencies

About the role

Key responsibilities & impact

Design, plan, and execute biostatistical components of research and development projects for medical device products
Conduct studies using sound statistical methodology throughout the product life cycle
Prepare statistical components of clinical trial protocols meeting project objectives, health authority guidelines, and clinical trial methodology standards
Develop and/or apply statistical theories, methods, and software
Summarize and interpret data in tabular and graphical formats
Prepare statistical components of study reports, outcomes, methods, regulatory submissions, and manuscripts
Provide specifications and directions to clinicians and statistical programmers
Support regulatory review and approval of experimental therapies
Partner on trial design, clinical conduct standards, and data collection, management, and reporting
Calculate sample size and power and determine appropriate design assumptions
Identify and manage threats to study credibility and validity
Write statistical analysis plans
Perform statistical analyses using statistical programming software such as SAS and R
Respond to questions from the FDA, FDA Advisory Panels, and other regulatory agencies
Participate in negotiations with regulatory agencies regarding study design and interpretation
Validate and clearly document analysis programs
Write Results and Methods sections of reports and manuscripts
Consult with non-clinical staff on statistical and analysis issues
Lead development of departmental and statistics-group policies and procedures
Mentor and train Statisticians and Senior Statisticians
Attend and contribute to project and department meetings

Requirements

What you’ll need

Bachelor’s degree with a minimum of 7 years of statistics (biostatistics or data analysis) experience, or an advanced degree with a minimum of 5 years of statistics experience
Master’s degree or PhD in Biostatistics, Statistics, or equivalent preferred
7+ years of post-graduate statistical experience preferred
Experience analyzing data from clinical studies and designing 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
Advanced knowledge of statistical programming packages, including SAS, R, or another statistical analysis package
Experience communicating complex statistical or machine-learning results to technical and non-technical audiences through publications, conferences, presentations/posters, and seminars
High level of knowledge of clinical trial methods and execution
Experience with Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices, including ISO and MDD/MDR
Prior experience with 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 in written and verbal form
Baccalaureate degrees earned outside the United States must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A)
Must possess unrestricted U.S. work authorization at the time of hire and for the duration of employment unless eligible for Principal-level sponsorship

Benefits

Comp & perks

Competitive benefits package
Short-term incentive through the Medtronic Incentive Plan (MIP)
Health insurance
Dental insurance
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 with employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement
Capital Accumulation Plan for eligible Vice Presidents and employees meeting IRS earning minimums
Paid sick time for temporary employees as required by applicable state law
Reasonable accommodations for qualified individuals with disabilities