AtriCure
Published
04/06/2021
Location
Mason
Category
Job Type
Contact Name
Rita Walstrom
Street Address
7555 Innovation Way

Description

As a leading provider of innovative technologies for the treatment of Atrial Fibrillation (Afib) and related conditions, electrophysiologists and cardiothoracic surgeons around the globe count on AtriCure to deliver best-in-class solutions that can treat even the most complex cases. Our Isolator® Synergy™ Ablation System is the first and only medical device approved by the FDA for the treatment of long standing persistent Afib, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, and we are expanding into pain management therapies. We invest in innovation, clinical science, and education to focus on improving lives for our patients’ worldwide.

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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