AtriCure

Sells ablation devices for atrial fibrillation

Senior Principal Statistician

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours

Full-timeNo salary listed

About the Job

Requirements

A Master’s or PhD in Statistics, Biostatistics, or a related field.
At least 3–5 years of experience in medical device, biotechnology, or pharmaceutical development for PhD holders, or 6–10 years for Master’s holders.
At least 2 years of management experience.
Knowledge of statistical methodology.
Strong oral and written communication skills.
Knowledge of study design, data analysis methodology, and SAS programming to meet Food and Drug Administration and International Council for Harmonisation guidelines.
Knowledge of programming Tables, Listings, and Figures in SAS for Food and Drug Administration submissions.
Knowledge of SAS, R, and sample size calculation software.
Ability to work independently.
Ability to travel 10%.
Ability to regularly walk, sit, or stand as needed.
Ability to occasionally bend and push or pull as needed.
Ability to pass a pre-employment drug screen and background check.

Responsibilities

Support the design, analysis, and reporting of trial results.
Develop statistical methodology for studies, including power analysis, randomization schemes, statistical analysis plans, subgroup analysis, and interim analysis.
Ensure data collection instruments are designed to capture protocol-specified scientific information and study databases.
Present statistical concepts, evidence, interpretations, and logical arguments to project teams, management, and regulatory agencies.
Develop program verification procedures and plans to provide thorough reviews of documentation and analysis output.
Deliver accurate and understandable line listings and statistical tables, and prepare and review statistical sections of study reports and submission reviews.
Program and validate derived datasets, Tables, Figures, and Listings.
Oversee the work of statistical programmers and contract research organization and vendor deliverables.
Manage statistics and statistical programming resources to meet assigned project priorities.
Contribute to timelines and budgets across functional teams to support timely submissions.
Collaborate with Data Management and contribute to case report forms, data management plans, and other Data Management deliverables.
Provide statistical input and review for annual progress reports, clinical study reports, and publications to ensure accurate statistical content in scientific reports.
Develop and routinely review Statistics and Statistical Programming standard operating procedures to maintain quality processes aligned with regulations.
Participate in regulatory submissions, including Investigational Device Exemptions and 510(k) submissions.
Hire, mentor, manage, and evaluate statistics and programming personnel as necessary.
Delegate assignments, review activities, and define and ensure review of deliverables so projects are completed on time and with high quality.
Maintain regular and predictable work performance.
Work under fast-paced conditions, make decisions using good judgment, and prioritize and multitask as required.
Perform additional duties as assigned.

Desired Qualifications

Expertise in medical device product development and experience interacting with regulatory agencies.
A PhD in Statistics, Biostatistics, or a related field with at least 4 years of experience in medical device, biotechnology, or pharmaceutical development.
At least 2 years of management experience.
Experience interacting with the Food and Drug Administration and other regulatory agencies.
Comprehensive experience programming Tables, Listings, and Figures for regulatory submissions.
Experience supporting 510(k), Investigational Device Exemption, premarket approval, New Drug Application, Biologics License Application, or Common Technical Document submissions.

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. 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. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

POSITION SUMMARY:

Reporting to the Vice President, Clinical Affairs and Biometrics, the Senior Principal Statistician is responsible for providing Statistics/Statistical Programming services. The Senior Principal Statistician will work closely with regulatory, scientific affairs, health economics, medical affairs and other departments to ensure optimal study designs, data collection and analysis for regulatory agencies and other stakeholders. 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.

ESSENTIAL FUNCTIONS OF THE POSITION:

Supports the design, analysis, and reporting of trial results
Develops statistical methodology for studies, including power analysis, randomization schemes, and statistical analysis plan, subgroup analysis, interim analysis, etc.
Ensures data collection instruments are designed to capture protocol-specified scientific information and study databases
Effectively presents statistical concepts, evidence, interpretations, and logical arguments to the project team, management, and regulatory agencies
Develops program verification procedures and plans to provide thorough and detailed reviews of documentation and analysis output
Delivers appropriate, accurate and understandable line listings and statistical tables, and preparation and review of statistical sections of study reports and submission reviews
Programming and validation of derived datasets Tables, Figures and Listings
Oversees work of statistical programmer and CRO/vendor deliverables
Manages statistics/statistical programming resources to meet assigned project priorities
Contributes to development of timelines and budgets across functional teams to ensure timely submissions aligned with our objectives
Works in close collaboration with Data Management and contributes to the development of CRFs. DMP and other DM deliverables
Provides statistical input and review for APRs, CSRs, publications to ensure the accuracy of the statistical component of scientific reports with high quality
Develops and routinely reviews Statistics/Statistical Programming SOPs to ensure adequate processes are in place to manage quality work in line with regulations.
Participates in regulatory submission process, including IDEs and 510(k)
Hires, mentors, manages and evaluates activities of statistics/programming personnel as necessary
Manages personnel by appropriately delegating assignments, reviewing activities and defining and ensuring review of deliverables so that projects are completed on time with high quality

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

Regular and predictable work performance
Ability to work under fast-paced conditions
Ability to make decisions and use good judgment
Ability to prioritize various duties and multitask as required
Ability to successfully work with others
Additional duties as assigned

BASIC QUALIFICATIONS:

MS/PhD in Statistics, Biostatistics or a related field. At least 3-5 years (PhD) or 6-10 years (MS) experience in medical device, biotech or pharmaceutical development. Minimum of 2 years of management experience. Knowledge of statistical methodology. Expertise in medical device product development and experience interacting with regulatory agencies highly desirable
Good communication skills, both oral and written
Knowledge of design, data analysis methodology, SAS programming to meet FDA and ICH guidelines
Knowledge of programming Tables, Listings and Figures in SAS for FDA submission
Good know of SAS, R and Sample size calculations software
Ability to work independently
Ability to travel 10%

PREFERRED QUALIFICATIONS:

PhD in Statistics, Biostatistics or a related field with at least of 4 years of experience in medical device, biotech or pharmaceutical development
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

OTHER REQUIREMENTS:

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

#LI-JH1

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits.

AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

You may access our global privacy policy here: https://www.atricure.com/privacy

About the Company

AtriCure

Sells ablation devices for atrial fibrillation

AtriCure develops medical devices for atrial fibrillation (AF), including ablation systems, left atrial appendage management devices, and cryoablation tools used in open-heart and minimally invasive heart surgeries. Their devices deliver energy to heart tissue to create controlled lesions or support blood flow, helping treat AF and reduce stroke risk. They differentiate themselves with an AF-focused portfolio and provide hands-on training and support for clinicians to ensure proper use across surgical approaches. Their goal is to improve patient outcomes by offering reliable tools and comprehensive clinician education.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Mason, OH
Founded: 1994

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