Associate Director, Biostatistics, Clinical Science

Company: Disability Solutions
Location: Irvine
Posted on: September 19, 2023

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.

Keywords: Disability Solutions, Irvine , Associate Director, Biostatistics, Clinical Science , Executive , Irvine, California