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J&J Family of Companies Staff Biostatistician in Carson City, Nevada

Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Biostatistician, located in Irvine, CA.

Consideration will also be given to candidates able to work remotely in the Pacific Time Zone of the United States. Strong preference to onsite work location of 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 Staff Biostatistician will be accountable for the development and execution of statistical strategy in accordance with applicable regulations for global pre- and post-market clinical trials.

Key Responsibilities:

  • Provide guidance on standards, processes, and technical direction within the biostatistics team.

  • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.

  • Assist in developing strategy for clinical trials and research

  • Assume a leadership role in the design and execution of statistical plans for all phases of clinical studies

  • Review clinical study protocols and Case Report Forms (CRFs) for proposed studies

  • Mentor junior statisticians on study design, protocol development, analyses and publication strategy

  • Interact with regulatory agencies to support the review process of statistical methodology employed in clinical trials

  • Stay current with statistical research and the use of novel methodology in clinical trial design and analysis

Qualifications

Required:

  • Master’s degree in Statistics. PhD preferred.

  • At least 8 years of experience (or 6 years with a PhD) in clinical research within Medical Device or Pharmaceuticals

  • Demonstrated technical leadership in delivering critical milestones

  • Experience with survival analysis, longitudinal data analysis, and frequentist and Bayesian adaptive designs

  • Proficient in SAS

Preferred:

  • Experience with cardiovascular and/or neurovascular clinical trials

  • Experience programming with R

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-

Other Locations

United States-Nevada, United States-Oregon, United States-Washington, United States-California

Organization

Biosense Webster Inc. (6010)

Job Function

R&D

Requisition ID

2276191217

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