Senior Principal Statistician, Medical Device Analytics

AtriCure, Inc.; Minnetonka (MN); On-site; USD 140,000 - 200,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1

401K match

Parental Leave

Volunteer Time off

Pet Insurance

On-site gym & cafeteria

Job summary

AtriCure, Inc. seeks a Senior Principal Statistician to lead Statistical Programming activities for regulatory submissions and study analyses.

Reporting to Clinical Affairs, you will shape study designs, data collection, and analysis plans across projects, ensuring timely, high-quality deliverables. You will mentor teams, coordinate with regulatory and medical affairs, and establish SOPs to support IDEs and 510(k) submissions.

Qualifications

• MS/PhD in Statistics or Biostatistics with relevant medical device/pharma experience.
• Experience in medical device, biotech or pharmaceutical development preferred.
• Management experience is desirable.

Responsibilities

• Design, analyze, and report trial results.
• Develop statistical methodologies for studies including power analysis and interim analyses.
• Ensure data collection instruments capture required information and are suitable for regulatory submissions.
• Prepare and review statistical sections of study reports and regulatory submissions.
• Oversee programming deliverables and ensure high-quality outputs.

Skills

Statistical programming

SAS

R

Leadership

Regulatory knowledge

Education

MS/PhD in Statistics

Tools

SAS programming

Sample size software

Job description

AtriCure, Inc. seeks a Senior Principal Statistician to lead Statistical Programming activities for regulatory submissions and study analyses.

Reporting to Clinical Affairs, you will shape study designs, data collection, and analysis plans across projects, ensuring timely, high-quality deliverables. You will mentor teams, coordinate with regulatory and medical affairs, and establish SOPs to support IDEs and 510(k) submissions.