Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director of Biostatistics, to be located in Santa Ana, CA or Jacksonville, FL.

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

You will lead and direct research related activities to ensure high quality programs, generate timely results, and provide excellent products and services to members.

Essential Responsibilities

•Develops annual research program proposals and related budgets, long-range research proposals, and technical progress reports.

•Collaborates with business development, technology assessment, and others to define a diagnostic product pipeline that provides medical value.

•Oversees one or more product pipelines, and the filling and balancing of those pipelines.

•Creates a motivated and focused team aligned with the organizational goals of the department and with company policy.

•Works together with the research and development solutions team and the operational division collaborating in new product and technology development activities and identifying development projects relevant to the company's long-term objectives and.

•Hires research staff, implements training and development initiatives to optimize staff skills, conducts performance appraisals, and develops individual objectives for direct report staff.

•Ensures development of future leaders.

•Leads and governs one or more research and development departments by taking ownership of the creation and execution of business processes.

•Provides technical expertise, in terms of problem solving for complex technical problems using advanced knowledge and experience.

Main areas of responsibility

•Provides statistical expertise to assist in the proper design of clinical trials studies and statistical methodology, calculates needed sample size and estimates trial power. Establishes randomization scheme and instructs staff in its use. Reviews CRF design and consults with clinical trial monitors.

•Provides statistical subject matter expertise to clinical/medical groups and Biostatistics staff in preparing analysis plans for reporting clinical trials results, determining details of data analysis and statistical methods, and formatting tables/listings/graphs for result presentation. Supports QA/QC to ensure the production of high quality statistical reports in a timely fashion. Works independently to review results and write statistical reports. Presents and discusses results with clinical groups and regulatory. Collaborates with clinical/medical writers on production of integrated clinical and statistical reports.

•Participates in various company committees and develops work flow and SOPs to streamline the Biostatistics and data management operation. Interacts with Biostatisticians at regulatory agencies as necessary to ensure that appropriate statistical techniques and procedure are employed.

•Obtains working knowledge of regulatory and ISO 9000 quality system requirements and Biostatistics SOPs. Participates in internal and external technical meetings, workshops and seminars to keep abreast of new developments in the field of statistics and biomedical areas relevant to company research interests. Serves as the Biostatistics representative at FDA and other notifying bodies. Represents the department or the company both internally and externally in a highly professional manner.

Qualifications

•Ph.D., in Statistics, Biostatistics or a related field is required

•Minimum of 10 years' experience of advanced statistical work is required

•SAS programming experience is required

•Ophthalmology experience highly preferred

•Ability to support 10% domestic and international travel is required.

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-Florida-Jacksonville-
Other Locations
United States-California-Santa Ana
Organization
Johnson & Johnson Vision Care, Inc. (6094)
Job Function
R&D
Requisition ID
9126200727