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LEAD CLINICAL BIOSTATISTICIAN

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Job Description


Biosense Webster, Inc., part of the Johnson & Johnson Family of companies, is currently recruiting for a Lead Biostatistician, to be located in Irvine, CA.

 

Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

 

The Lead Biostatistician will be primarily responsible for the statistical design and analysis of clinical and observational studies in support of Johnson & Johnson’s Mentor breast implant devices.

 

The Lead Biostatistician will:

 

  • Work closely with clinical teams in designing clinical studies, leading/authoring the statistical analysis plan, conducting the statistical analysis, and providing statistical input to the clinical study report.
  • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and deliver project requirements.
  • Design and execute statistical plans for different phases of clinical studies independently, assuming a leadership role in creating strategy for study design and analyses.
  • Perform and interpret exploratory statistical analyses in support of Mentor implant devices
  • Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions
  • Review clinical study protocols, clinical study reports, and publications with respect to statistical methodology.
  • Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.
  • Oversee production of presentation materials for professional meetings, and may assist in presenting information at these meetings.



Qualifications

Requirements:

 

  • Master’s degree (PhD preferred) in Statistics or Biostatistics required
  • At least 6 years of experience (or 4 years with a PhD) in clinical research within Medical Device or Pharmaceutical industries required
  • Knowledge of statistical methods for clinical trials required
  • Thorough understanding of statistical inference preferred
  • Experience with statistical modeling for continuous and categorical data, survival analysis, longitudinal data analysis, and other statistical methodologies required
  • Knowledge of statistical methods for observational studies.
  • Proficiency in SAS and/or R statistical software required
  • Excellent verbal and written communication skills.
  • Knowledge of Microsoft packages; PowerPoint, Excel, Word.

 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



Primary Location
United States-California-Irvine-
Organization
Biosense Webster Inc. (6010)
Job Function
Biostatistics
Requisition ID
8015191018