Associate Director, Biostatistics, Clinical Science - Irvine, CA / Jacksonville, FL / Milpitas, CA / Possible Remote

Key Skills

Biostatistics, Data Analysis, Data management, Design, Effective communication skills, Leadership Skill, R Programming, SAS, Statistics, Teamwork

Job Description

Johnson & Johnson Surgical Vision Inc., a member of the Johnson & Johnson Family of Companies, is currently recruiting for an Associate Director, Biostatistics, Clinical Science who is creative and motivated, passionate about clinical trials and innovation in statistical research to help meet the unmet needs to vision correction. The primary and preferred location for this position is Irvine, CA. Secondary preference is for Jacksonville, FL, or Milpitas, CA. Remote work options within the US may be considered on a case-by-case basis and if approved by the Company.

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’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 & Johnson Vision on LinkedIn.

Position Summary

As a member of the Biostatistics and Data Management Leadership Team, the Associate Director will lead a team of statisticians to ensure the quality and appropriateness of clinical trial designs and statistical analyses methods. Will foster and promote statistical innovation in product development. Will be involved in developing statistical regulatory strategies for clinical trials including study design, clinical data analysis, and reporting of clinical data across the Surgical Vision and Vision Care businesses. The candidate will provide statistical expertise on regulatory briefing documents and worldwide regulatory submissions.

Key Responsibilities

• Provide leadership and long-term vision to the Biostatistics group to support Johnson & Johnson Vision’s clinical, regulatory and business objectives.
• Subject matter expert (SME) in Biostatistics representing the company in communications/ interactions with regulatory agencies and business partners within the organization.
• Foster and support the implementation innovative clinical trial designs, novel analysis methods such as adaptive designs, integration of RWD and historical control data, and Bayesian methodologies.
• Experience in interactions and shown effective communication with the FDA and worldwide regulatory agencies, in meetings and in submissions (e.g. briefing documents).
• Responsible for providing responses to Health Authorities queries relating to study design, data analysis, and output interpretation posed by clinical monitors, regulatory agencies, and/or investigators.
• Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of experience in design, development and implementation of a clinical trial protocol, and simulation studies.
• Partner with cross-functional colleagues in Clinical Science, Clinical Operations, and Regulatory Affairs and be able to communicate statistical concepts and approaches to non-statisticians.

• Guide internal and external Biostatistics members to complete statistical deliverables on time and with high quality.
• Hire staff, implement training and development initiatives to optimize staff skills, conduct performance appraisals, and develops individual objectives for direct reports.
• Ensure development of future leaders by providing growth opportunities for biostatisticians.

Qualifications

• MS degree in Statistics/Biostatistics or related field with at least 12 years related experience or PhD in Statistics/Biostatistics or related field with at least 6 years of experience is required.
• At least 2 years of experience in clinical trial research is required.
• Proficient in both SAS and R is required. Knowledge of other relevant statistical tools or other computer programming languages is desired.
• Experience in at least one of the following statistical innovation areas is required: adaptive clinical study designs, Bayesian trials and/or analysis methods, RWD/RWE integration in product development.
• Experience in interacting with regulators at the FDA, and/or other regulatory agencies, specifically in the biostatistics field is required.
• Some experience in people management (1+ direct reports) is preferred.
• Some knowledge of the regulatory approval process for medical devices is preferred.
• Excellent oral and written communication skills are required.
• Preferred location for this position is Irvine, CA. With secondary preference for Milpitas, CA, or Jacksonville FL. Consideration may be given for remote work arrangements within the US.
• Ability to travel 25-50% domestically is required.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. 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.

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’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. The anticipated base pay range for this position is $131,000 to $225,000. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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 .

https://www.careers.jnj.com/data-science