Senior Principal Statistician - Medical Device Analytics Leader

AtriCure, Inc.; Mason (OH); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical & Dental

401K with match

Parental Leave (paid)

On-site fitness center

Job summary

AtriCure, Inc. in the United States is seeking a Senior Principal Statistician to provide Statistics/Statistical Programming services across regulatory and medical affairs functions. You will design analyses, develop SAPs, and deliver Tables, Figures and Listings for submissions.

The role emphasizes standard processes, collaboration with cross-functional teams, and leadership of statistics/programming resources to meet project priorities and timelines.

Qualifications

• MS/PhD in Statistics or Biostatistics with 3–5 years (PhD) or 6–10 years (MS) in medical device/pharma development.
• Strong communication skills, both oral and written.
• Knowledge of SAS programming to meet FDA/ICH guidelines.
• Experience programming Tables, Listings and Figures in SAS for submissions.
• Willingness to travel up to 10%.

Responsibilities

• Supports the design, analysis, and reporting of trial results.
• Develops statistical methodology for studies, including power analysis and interim analyses.
• Ensures data collection instruments capture protocol-specified information.
• Effectively presents statistical concepts to teams, management, and regulators.
• Delivers appropriate line listings and statistical tables and lists.
• Oversees CRO/vendor deliverables and manages statistics/programming resources.
• Contributes to timelines and budgets for regulatory submissions.

Skills

Statistical methodology

Regulatory interaction

People management

Communication skills

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

Sample size calculations software

Job description

AtriCure, Inc. in the United States is seeking a Senior Principal Statistician to provide Statistics/Statistical Programming services across regulatory and medical affairs functions. You will design analyses, develop SAPs, and deliver Tables, Figures and Listings for submissions.

The role emphasizes standard processes, collaboration with cross-functional teams, and leadership of statistics/programming resources to meet project priorities and timelines.