Statistician -Medtronic Clinical Research Solutions (MCRS) - On-site, Minneapolis, MN

Medtronic hires a Statistician for Medtronic Clinical Research Solutions (MCRS) to support clinical research studies through statistical design, analysis, interpretation, and reporting. The role partners with cross-functional teams to develop statistical approaches and deliver evidence supporting medical device development and regulatory objectives.

Responsibilities

• Design and execute statistical analyses for clinical research studies evaluating the safety and effectiveness of medical devices
• Develop statistical sections of clinical study protocols and analysis plans aligned with study objectives and regulatory requirements
• Program, validate, and perform statistical analyses using SAS and/or R to support clinical evidence generation
• Analyze, summarize, and interpret clinical data, delivering statistical outputs, reports, and study results for internal and regulatory stakeholders
• Partner with clinical, regulatory, data management, and statistical programming teams to support study execution and submission activities
• Provide statistical guidance on study design, data collection, reporting standards, and regulatory interactions

Preferred

• Master's degree in Biostatistics, Statistics, or Epidemiology
• Experience supporting clinical research within a Clinical Research Organization (CRO), medical device, pharmaceutical, or biotechnology environment
• Knowledge of Good Clinical Practice (GCP) and medical device or clinical trial regulatory requirements, including ISO, Medical Device Directive (MDD), or Medical Device Regulation (MDR)
• Experience with clinical research data management and relational databases
• Proficiency with Microsoft Office applications, including Excel and Word
• Experience communicating statistical concepts and study results to technical and non-technical audiences
• CRO Experience
• Medical Device Industry Experience
• Pharmaceutical Industry Experience
• Biotechnology Industry Experience
• Clinical Practice (GCP)
• Clinical Trial Regulations
• Medical Device Regulations
• ISO Standards
• Medical Device Directive (MDD)
• Medical Device Regulation (MDR)
• Clinical Research Data Management
• Relational Databases
• Microsoft Office
• Microsoft Excel
• Microsoft Word
• Statistical Concepts
• Study Results Communication
• Technical Communication
• Audience-Adaptive Communication

Benefits

• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• For regular employees who work 20+ hours per week: Health, Dental and vision insurance
• For regular employees who work 20+ hours per week: Health Savings Account
• For regular employees who work 20+ hours per week: Healthcare Flexible Spending Account
• For regular employees who work 20+ hours per week: Life insurance
• For regular employees who work 20+ hours per week: Long-term disability leave
• For regular employees who work 20+ hours per week: Dependent daycare spending account
• For regular employees who work 20+ hours per week: Tuition assistance/reimbursement
• For regular employees who work 20+ hours per week: Simple Steps (global well-being program)
• For all regular employees: Incentive plans
• For all regular employees: 401(k) plan plus employer contribution and match
• For all regular employees: Short-term disability
• For all regular employees: Paid time off
• For all regular employees: Paid holidays
• For all regular employees: Employee Stock Purchase Plan
• For all regular employees: Employee Assistance Program
• For all regular employees: Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• For all regular employees: Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
• Temporary employees: paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan

Company

• Global healthcare technology company
• Minneapolis, Minnesota, USA
• https://www.medtronic.com/
• Founded in 1949
• 10001+ employees

Qualifications

• Bachelor's degree and 2+ years of biostatistics, statistics, epidemiology, or clinical research experience OR Master's degree and 0+ years of experience
• Experience applying statistical methods to clinical, healthcare, or research data
• Experience with SAS and/or R programming
• Experience analyzing and interpreting data and presenting results through tables, figures, and statistical reports
• 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
• 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
• Master's degree in Biostatistics, Statistics, or Epidemiology
• Experience supporting clinical research within a Clinical Research Organization (CRO), medical device, pharmaceutical, or biotechnology environment
• Knowledge of Good Clinical Practice (GCP) and medical device or clinical trial regulatory requirements, including ISO, Medical Device Directive (MDD), or Medical Device Regulation (MDR)
• Experience with clinical research data management and relational databases
• Proficiency with Microsoft Office applications, including Excel and Word
• Experience communicating statistical concepts and study results to technical and non-technical audiences
• Bachelor's degree and 2+ years of biostatistics, statistics, epidemiology, or clinical research experience OR Master's degree and 0+ years of experience.

Required skills

• Biostatistics, Clinical Data Analysis, Clinical Practice (GCP), Clinical Research, Clinical Research Data Management, Medical Device Regulations, Microsoft Excel, Microsoft Word, R, Relational Databases, SAS, Statistical Methods

Experience

• 2+ years