Senior Clinical Biostatistician

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Job Description

Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants

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The Senior 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.


Additional responsibilities include:

  • 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 reports.

  • 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

  • Produce presentation materials for professional meetings and may assist in presenting information at these meetings.




  • Master’s degree (PhD preferred) in Statistics or Biostatistics required.
  • At least 4 years of experience (or 2 year 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 required
  • Experience with statistical modeling for continuous and categorical data, survival analysis, longitudinal data analysis, and other statistical methodologies.
  • 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-
Biosense Webster Inc. (6010)
Job Function
Requisition ID