Senior Principal Statistician, Medical Device Analytics

AtriCure, Inc.; United States; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical & Dental from day 1

401K + match

Parental Leave (30 days)

Volunteer Time Off

Pet Insurance

On-site fitness center

Cafeteria

Job summary

AtriCure, Inc. seeks a Senior Principal Statistician to lead statistics/programming for regulatory submissions. You will design analyses, create SAPs, and deliver tables, listings, and figures, guiding junior staff and CROs to ensure quality in line with FDA/ICH standards.

The role involves cross-functional collaboration with Regulatory, Medical Affairs, Data Management and other teams, mentoring staff, and contributing to SOPs and timelines for multiple submissions.

Qualifications

• MS/PhD in Statistics, Biostatistics or related field. 6–10 years (MS) or 3–5 years (PhD) experience in medical device/biotech/pharma development.
• Minimum of 2 years of management experience. Knowledge of regulatory interactions with FDA/ICH guidelines is highly desirable.
• Strong programming experience in SAS; ability to generate Tables, Listings and Figures for submissions.

Responsibilities

• Design, analysis, and reporting of trial results.
• Develop statistical methodologies for studies, including power analysis and interim analyses.
• Ensure data collection instruments capture protocol-specified information and study databases.
• Present statistical concepts clearly to project teams and regulators.
• Develop verification procedures for output and documentation.

Skills

Statistics

Biostatistics

Regulatory interactions

Study design

SAS programming

R

Data analysis

Presentation to stakeholders

Leadership

Project management

Education

MS/PhD in Statistics or Biostatistics

Tools

SAS

R

Job description

AtriCure, Inc. seeks a Senior Principal Statistician to lead statistics/programming for regulatory submissions. You will design analyses, create SAPs, and deliver tables, listings, and figures, guiding junior staff and CROs to ensure quality in line with FDA/ICH standards.

The role involves cross-functional collaboration with Regulatory, Medical Affairs, Data Management and other teams, mentoring staff, and contributing to SOPs and timelines for multiple submissions.