Johnson & Johnson Vision, part of the Johnson & Johnson Family of Companies is currently recruiting for a Senior Biostatistician II located in 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.
The Senior Biostatistician II will take the lead statistical role on several clinical trials by providing study design expertise via protocol development and review of case report forms, selection of endpoints, sample size calculations, randomization, and the development of statistical analysis plans (SAP). Contribute to the development and implementation of novel statistical methods to solve R&D problems
You will be responsible in conducting statistical analysis and inference, writing and presenting reports summarizing findings in support of product development. You will collaborate with SAS programmer analysts to generate tables, listings and figures and derived datasets that summarize results for clinical trials. These efforts must meet company objectives and satisfy regulatory, GCP, and ICH requirements and guidelines.
• A minimum of a Master’s in Statistics with 6 years of experience as a Biostatistician in medical research OR a Ph.D. in Statistics with a minimum of 4 years of experience as a Biostatistician in medical research
• Experience in medical device or pharmaceutical clinical trials
• Experience with regulatory submission (NDA, PMA or 510k)
• Excellent analytical skills
• Experience in statistical programming with SAS
• Ability to effectively communicate with a multi-disciplinary project team, work independently and meet deadlines
• Attention to detail, quality and accuracy
• Experience of Bayesian methods and simulation
• Knowledge of CDISC data standards: STDM and ADaM
This position may require up to 10% domestic travel.
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.
Johnson & Johnson Vision Care, Inc. (6094)