Senior Biostatistician - JNJ MedTech Vision at Johnson & Johnson in Irvine, CA

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Job Description

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 At Johnson &amp; Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That&rsquo;s why, through our operating companies, we&rsquo;ve developed solutions for every stage of life&mdash;to help people see better, connect better, and live better. We partner with eye care professionals to provide some of the world&rsquo;s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson &amp; Johnson on LinkedIn.
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 Johnson &amp; Johnson Vision, Clinical Science division has an opening on the Biostatistics team for a Senior Biostatistician, to be located in Irvine CA, or Milpitas CA, or Jacksonville FL. We are seeking a talented and motivated individual who is passionate about clinical trials and statistical research to help meet the unmet needs for vision correction.
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 The Senior Biostatistician provides statistical expertise to plan and complete statistical activities including design, analysis, interpretation, and reporting or communication of data evidence for research, development, and/or marketed product needs in JNJ MedTech, Vision.
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  Key Responsibilities:
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   This position supports all statistical aspects related to clinical trials, marketing efforts, and research studies.
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   Edits and finalizes statistical analysis plans and system programming plans for all phases of clinical studies and reports on the findings of statistical analyses and publications in preparation for new product applications to regulatory agencies.
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   Demonstrates data analytic expertise based on a foundation of statistical principles related to: design, development and implementation of a clinical trial protocol, clinical database, and/or simulation studies.
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   Is effective in the use of relevant computational tools for study design or statistical analyses of clinical data.
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   Ensures application of high-quality statistical methods in writing statistical analysis plans and generation of accurate and reproducible statistical analyses of clinical trial outcomes, by working independently and/or in collaboration with colleagues.
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   Design tables/figures/listings and analysis datasets specifications for statistical programmers
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   Produces clear, concise, well-organized, and error-free computer programs and statistical reporting analyses.
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   Ensures that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency
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   Is accountable for execution of project responsibilities including: meetings with project team members, completing statistical deliverables, run a wide range of analyses/graphics.
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   Has very good written, oral, and interpersonal communication skills.
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   Abides by the Credo and practices J&amp;J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.
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   Proven track record to collaborate with statisticians, data managers and clinical scientists.
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  Qualifications:
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   PhD in Statistical Sciences/Biostatistics or related fields with 1+ years related experience or Master of Science in Statistics/Biostatistics with 2+ related experience is required.
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   Some knowledge of novel statistical methods such as for example Bayesian modeling, historical control, or high dimensional data is required.
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   Shows strong skills in SAS and some knowledge of R are required; knowledge of other relevant statistical tools and software is desirable.
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   Open to learn new statistical skills and ready to think out-of-the-box for problem solving solutions.
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   Open to do intensive SAS programming occasionally.
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 Working form one of the company offices either in Milpitas CA, or Irvine CA or Jacksonville FL is required.
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  Preferred:
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 Exposure to or experience with clinical trials for medical devices and/or in the ophthalmology field is preferred.
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 The anticipated base pay range for this position is $104,000 to $166,750. California Bay Area - The anticipated base pay range for this position is $119,000 to $191,820.
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 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation&rsquo;s performance over a calendar/performance year. Bonuses are awarded at the Company&rsquo;s discretion on an individual basis.
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   Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
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   Employees may be eligible to participate in the Company&rsquo;s consolidated retirement plan (pension) and savings plan (401(k)).
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   Employees are eligible for the following time off benefits:
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    Vacation &ndash; up to 120 hours per calendar year
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    Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington &ndash; up to 56 hours per calendar year
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    Holiday pay, including Floating Holidays &ndash; up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
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   Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
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 Johnson &amp; 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.
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 For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]
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AI Powered Job Insights

A fantastic opportunity has arisen for a Senior Biostatistician at Johnson & Johnson Vision, a leader in eye health solutions. This role is tailored for individuals who are passionate about clinical trials and statistical research aimed at improving vision correction technologies.

📍 Location: Irvine, CA, Milpitas, CA, or Jacksonville, FL  
đź’Ľ Position: Senior Biostatistician  
⏰ Type: Full-time  
đź“… Date Posted: July 23, 2024  

Role Summary:  
- They are seeking a talented individual who will provide statistical expertise for clinical trials and research studies.  
- The focus is on the design, analysis, interpretation, and reporting of statistical data for new product applications.

What You'll Do:  
- Support all statistical aspects related to clinical trials and marketing efforts.  
- Edit and finalize statistical analysis and programming plans.  
- Apply a variety of statistical methods in trial design, analysis, and reporting.  
- Collaborate with project teams to ensure high-quality statistical methods are used.  
- Design specifications for statistical programmers and produce clear reports.  
- Maintain accountability for executing project responsibilities, completing analyses, and conducting meetings.  

What's Needed:  
- PhD in Statistical Sciences/Biostatistics or a related field with 1+ years of experience, or a Master’s degree in the same fields with 2+ years of experience.  
- Knowledge of statistical methods like Bayesian modeling is required.  
- Proficiency in SAS and familiarity with R are essential.  
- Willingness to engage in intensive SAS programming is preferred.  
- Exposure to clinical trials in the medical device or ophthalmology field is a plus.  

Compensation & Benefits:  
- Base pay ranges from $104,000 to $166,750; higher in the California Bay Area.  
- Eligible for an annual performance bonus and a competitive benefits package including medical, dental, vision, and retirement plans.  
- Generous vacation, sick time, and holiday pay are included as part of the benefits.  

This is a remarkable chance for biostatisticians aiming to make a significant impact in the healthcare sector, particularly in advancing eye health. Apply now to take your career to new heights!

Top Interview Questions

  • Q: Can you describe your experience in designing and analyzing clinical trial protocols?

    A: In my previous role as a biostatistician, I was involved in designing a Phase III clinical trial for a novel ophthalmic device. I developed the statistical analysis plan that included primary endpoints, secondary endpoints, and interim analyses. By collaborating closely with clinical scientists and regulatory teams, we ensured the trial met both scientific and compliance standards, leading to a successful submission to the FDA.

  • Q: What statistical methods do you utilize when working with clinical data, and how do you ensure their appropriateness?

    A: I typically use mixed-effects models and survival analysis for clinical data, especially in ophthalmology studies. To ensure appropriateness, I assess the data characteristics, including distribution and sample size. I also employ cross-validation techniques to confirm the robustness of the chosen methods, ensuring they yield reliable estimates and conclusions.

  • Q: Describe a situation where you had to communicate complex statistical findings to a non-statistical audience. How did you do it?

    A: In a project where I analyzed trial data for a new eye drop formulation, I presented the results at a company-wide meeting. I focused on the practical implications of the findings rather than the technical details. I used visual aids like graphs and charts to illustrate trends, making the results more accessible. The feedback was positive, and several team members noted that they appreciated the clarity of my explanation.

  • Q: How do you approach collaboration with clinical scientists and data managers during a project?

    A: I prioritize open communication and regular check-ins to align on project goals and timelines. For instance, during a recent device evaluation study, I set up weekly meetings with the project team to review progress and any challenges. This collaborative environment enabled us to address issues promptly and maintain momentum, resulting in timely statistical deliverables that supported the project’s success.

  • Q: Can you discuss your experience with novel statistical methods, such as Bayesian modeling or high-dimensional data analysis?

    A: I have experience with Bayesian modeling, particularly in adaptive trial designs. In one project, I utilized Bayesian methods to update the probability of success as data became available, which allowed for more flexible decision-making. Additionally, I have applied dimensional reduction techniques like PCA to handle high-dimensional data in exploratory analyses, resulting in actionable insights that guided the next stages of clinical development.

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