Senior Principal Statistician - Medical Device Analytics

AtriCure, Inc.; Mason (OH); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental

401K + match

Parental Leave

Volunteer Time off

Pet Insurance

On-site fitness center

Cafeteria access

Job summary

AtriCure, Inc. is seeking a Senior Principal Statistician reporting to the Vice President of Clinical Affairs and Biometrics to provide Statistics/Statistical Programming services.

You will work with regulatory, health economics, medical affairs, and other teams to ensure optimal study designs, data collection, and analyses for regulatory submissions. You will establish standard processes and best practices for statistical programming, SAPs, derived datasets, tables, figures and listings, and

Qualifications

• MS/PhD in Statistics, Biostatistics or related field; 3–5 yrs (PhD) or 6–10 yrs (MS) in medical device/biotech/pharma development.
• Strong communication skills, oral and written.

Responsibilities

• Supports design, analysis, and reporting of trial results.
• Develops statistical methodology for studies: power analysis, randomization, SAP, subgroup/interim analyses.
• Ensures data collection instruments capture protocol-specified info and study databases.
• Presents statistical concepts to project teams, management, and regulatory agencies.
• Delivers line listings, tables, figures, and listings; reviews outputs.

Skills

Statistics

Biostatistics

SAS programming

Clinical trials

Regulatory knowledge

Data analysis

Leadership

Education

MS in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Tools

SAS

R

Sample size calculations

Job description

AtriCure, Inc. is seeking a Senior Principal Statistician reporting to the Vice President of Clinical Affairs and Biometrics to provide Statistics/Statistical Programming services.

You will work with regulatory, health economics, medical affairs, and other teams to ensure optimal study designs, data collection, and analyses for regulatory submissions. You will establish standard processes and best practices for statistical programming, SAPs, derived datasets, tables, figures and listings, and