Senior Principal Statistician - Medical Device Lead

AtriCure, Inc.; Minnetonka (MN); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1

401K match

Parental Leave

Volunteer Time Off

Pet Insurance

On-site fitness center

Job summary

AtriCure, Inc. is seeking a Senior Principal Statistician to provide Statistics/Statistical Programming services across regulatory, scientific, and medical affairs teams. You will design studies, analyze data, and ensure robust submission-ready outputs including SAPs, tables, figures, and listings.

Lead statistical programming efforts, mentor staff, oversee CRO/vendor deliverables, and contribute to IDE/510(k) submissions with high-quality analytical input.

Qualifications

• MS/PhD in Statistics or Biostatistics; medical device/pharma development experience is preferred.
• Minimum 2 years of management experience in statistics/programming.
• Strong knowledge of FDA/ICH guidelines; excellent communication skills.

Responsibilities

• Design, analyze, and report trial results.
• Develop statistical methods for studies including power, randomization, and subgroup analyses.
• Manage statistical programming deliverables, SAPs, and derived datasets.

Skills

Statistics & Biostatistics

Medical device experience

Regulatory interaction

Communication

Leadership

Independent work

Education

MS/PhD in Statistics or Biostatistics

Tools

SAS

R

Sample size software

Job description

AtriCure, Inc. is seeking a Senior Principal Statistician to provide Statistics/Statistical Programming services across regulatory, scientific, and medical affairs teams. You will design studies, analyze data, and ensure robust submission-ready outputs including SAPs, tables, figures, and listings.

Lead statistical programming efforts, mentor staff, oversee CRO/vendor deliverables, and contribute to IDE/510(k) submissions with high-quality analytical input.