Title: Senior Statistician
Location: United States-New York-Rochester Global Eye Health Center Site
The ideal candidate will be able to work independently as the lead statistician on multiple medical device studies covering varying ophthalmic therapeutic areas. The position will entail applying statistical analysis and design knowledge (including accounting for correlation within a subject) andclinicaltrial experience to conceive and defend efficient study designs and analysis strategies. The ideal candidate is expected to be the primary statistical representative for high functioning cross functional study teams, being prepared to defend the chosen design and analysis strategies and be flexible enough to understand requests and how the chosen designs account for the requests.
Specific Job Duties
* Collaborate on protocol development including the design of the study, clarification of endpoints to meet objectives, calculation of power and sample size, and writing statistical sections.
* Review of case report forms, annotations, and edit checks to ensure capturing of all required data in a way that supports a high quality database for the planned analyses.
* Creation of randomization strategies and schedules.
* Writing and overseeing implementation of statistical analysis plans for multiple studies, creating summary templates and specifications. Support programming of summaries as necessary.
* Writing/reviewing statistical and outcome sections of study reports and submissions.
* Assess feasibility of analysis requests and associated timelines. Communicate/discuss data/analysis issues with team of programmers (SAS and Data Management), statisticians, and clinical managers.
· Serve as technical resource to multiple study teams. Develop and present new methods/techniques to team.
· Assist with process improvements and in building efficiencies across studies.
· Assist in defending strategy and findings to FDA.
Bausch Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.
· PhD in statistics or biostatistics with 2 years of experience or MS with 4 years of experience in applied statistics, preferably clinical trial experience.
· Demonstrated ability to lead multiple projects in a fast paced environment.
· Must have sound working knowledge of statistical theory and application including experimental design, categorical data analysis, linear models, non-parametric methods. Experience with group sequential methods and/or analysis of correlated data preferred. SAS programming in a clinical environment. Proficiency in Base SAS and SAS stat modules.
Job: Research/Development
