AtriCure
Senior Principal Statistician
United States of America · Principal · Contract
Sponsorship not specifiedDetected 4 hours ago
Data AnalysisStatisticsSAPFDA RegulatoryMedical DevicesSASCommunicationCollaborationBiostatistics
About the role
- Reporting to the Vice President, Clinical Affairs and Biometrics, the Senior Principal Statistician is responsible for providing Statistics/Statistical Programming services.
- This individual will be responsible for statistical programming deliverables: SAP, derived datasets, Tables, Figures and Listings.
- The Senior Principal Statistician will establish and ensure compliance with standard processes and industry best practices.
Responsibilities
- Supports the design, analysis, and reporting of trial results
- Develops and routinely reviews Statistics/Statistical Programming SOPs to ensure adequate processes are in place to manage quality work in line with regulations.
Requirements
- Knowledge of programming Tables, Listings and Figures in SAS for FDA submission
- Ability to work independently
- Ability to travel 10%
- Knowledge of statistical methodology.
Nice to have
- Minimum of 2 years of management experience
- Experience interacting with FDA and other regulatory agencies
- Statistician with comprehensive experience in programming TLFs for regulatory submissions
- Experience in supporting 510K, IDE, PMA, NDA, BLA, and or CTD submission
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to pass pre-employment drug screen and background check
- AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees.
Skills
- AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions.
- Afib affects more than 33 million people worldwide.
- AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.
- AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide.
- AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients.
- For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
Benefits
- https://www.atricure.com/careers-atricure/benefits.
Apply directly at AtriCure →Create a free account for alerts like thisView AtriCure immigration profile
This listing is sourced directly from AtriCure's careers page and normalized into a canonical job model.