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Senior Statistical Programmer Job in Cincinnati, Ohio US

Senior Statistical Programmer

Atricure, Inc. - Cincinnati, OH

Posted: 8/11/2022 - Expires: 11/9/2022

Job ID: 245632899

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Job Description

Senior Statistical Programmer

Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA
Req #800

Thursday, February 10, 2022

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: 


The Senior Statistical Programmer will provide technical statistical programming expertise and leadership to the clinical affairs department for AtriCure projects. This position will be responsible for devising analysis dataset specifications, programming of 


derived datasets, tables, listings and figures for clinical trials and other research. The position requires experience supporting 510 (K), IDE and PMA submissions and extensive experience in SAS programming and standards. The position will contribute 


in updating and developing standard operating procedures (SOP) related to statistical programming. Will oversee related activities of Contract Research Organizations (CROs).

*This is a hybrid remote/in-office position.


 


ESSENTIAL FUNCTIONS OF THE POSITION: 


* Programming of derived datasets and Tables, Figures and Listings (TFLs) based on derived dataset specifications and approved statistical analysis plan (SAP) 


* Develop derived dataset specifications 


* Validation (QC) of derived datasets and TFLs 


* Contributes to SAP by preparing Mock-Ups for TFLs 


* Provide input to CRF design, review CRF annotations and database/edit check specifications 


* Act as a consultant to other AtriCure associates and external customers on statistical programming issues 


* Lead efforts to set up statistical programming standards and processes within Clinical Affairs 


* Provide direction to consultants and contractors performing statistical programming duties for AtriCure 


* Hold CRO other partners accountable for on time and quality standard deliverables 


* In-depth knowledge of statistical computing applications such as Base SAS, SAS/STAT, ODS/RTF, ODS/GRAPH, SQL 


* Skilled in data-step/data derivation programming and SAS Macro programming 


* Comprehensive knowledge implementing common statistics methods and tests 


* Working knowledge of CDISC to create and SDTM and ADaM 


 


ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION: 


* Presentation skills to internal and external groups 


* Ability to effectively handle multiple tasks and projects 


* Organizational and time management skills 


* Knowledge of 510 (k), IDE and PMA submissions and interaction with FDA and regulatory bodies 


* Excellent cross-functional collaborative skills 


* Superior statistical programming skills 


 

BASIC QUALIFICATIONS:


* Bachelor's or Master's in statistics or related field 


* (BS + 5 years or MS + 4 years) experience in medical device or pharmaceutical and/or CRO environment 


* Must demonstrate the ability to program and QC analysis datasets, TFLs 


* Good knowledge of regulatory requirements: ICH E3, E9, etc. 


* Good knowledge of data management processes 


* Ability to work independently 


 


PREFERRED QUALIFICATIONS: 


* Master's in statistics or related field, with minimum of 4 years relevant experience 


 


OTHER REQUIREMENTS: 


* Ability to regularly walk, sit, or stand as required 


* Ability to occasionally bend and push/pull 


* Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds 


* Ability to pass pre-employment drug screen and background check

LI-RW1

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, 15 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/benefitsAtriCure 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).

Other details

Job Family
Clinical Affairs

Job Function
Clinical

Pay Type
Salary

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
63979937_2
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
N/A