Principal Biostatistician

Description:

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:
This position will be responsible for devising analysis plans, designing clinical trials, performing statistical analyses, generating randomization codes, performing sample size estimations for study protocols, writing statistical methods section of study protocols and writing statistical reports for clinical trials and other research. The position requires experience supporting 510 (K), IDE and PMA submissions and extensive experience in study designs, prospective, retrospective, patient registries and data mining of secondary databases, meta-analysis and publication of research results to drive market adoption. The position will contribute in updating and developing standard operating procedures (SOP) related to statistics and statistical programming. Will oversee related activities of Contract Research Organizations (CROs).

ESSENTIAL FUNCTIONS OF THE POSITION:

• Investigate and recommend optimal statistical methods for clinical trials
• Assist in the planning, designing, developing and implementing of a clinical trial protocol, clinical database, and data monitoring/data management
• Provide input for the case report form design and edit check specifications
• Develop statistical analyses plan for clinical study trial and performs statistical analyses of clinical trials
• Assist in the programming and/or QC of analysis datasets, Tables, Figures and Listings
• Provide input for clinical study design
• Write and support trial reports and publications
• Interpret statistical analyses and publications in preparation for new device applications to FDA and other regulatory bodies
• Act as a statistical consultant to other AtriCure associates and external customers on statistical and statistical programming issues
• Lead efforts to set up statistical and programming standards and processes within Clinical Affairs
• Provide statistical training, upon request, to statisticians and non-statisticians on statistical methods
• Provide direction to consultants and contractors performing statistics and programming duties AtriCure
• Hold CRO other partners accountable for on time and quality standard deliverables

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Excellent presentation skills to internal and external groups
• Organizational and time management skills
• Superior knowledge of current statistical literature and research design/execution methods
• Excellent knowledge of PMA/IDE medical device submission regulations
• Ability to proactively and creatively apply statistical problem-solving techniques and decision-making skills to trial planning exercises
• Excellent cross-functional and inter-organizational collaborative skills
• Superior statistical programming skills
• In depth knowledge of CSR development

BASIC QUALIFICATIONS:

• MS with major in Biostatistics (or equivalent) and minimum of 8 years experience in the medical device or pharmaceutical industry, orPhD with 5 years experience in the medical or pharmaceutical industry
• Must have at least 3 years of SAS statistical programming experience
• Must demonstrate the ability to program and QC analysis datasets, Tables, Figures and Listings
• Good knowledge of regulatory requirements: ICH E3, E9, etc.
• Experience in preparation of PMAs, IDEs and 510 (k)
• Good knowledge of data management processes
• Experience writing SAPs (with mock TLFs), CSR, performing sample size calculations for studies
• Ability to work independently

PREFERRED QUALIFICATIONS:

• Ph.D. in Statistics, Biostatistics or equivalent with minimum of 5 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

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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/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).