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Senior Statistician Job

Date: Nov 3, 2009

Location: Rochester, NY, 14673, USA

Job Title:
Senior Statistician

Req #:
5294BR

Job Description:
The ideal candidate will be able to work independently as the lead statistician on multiple studies covering varying ophthalmic therapeutic areas. The position will entail applying statistical analysis and design knowledge (including accounting for correlation within a subject) and pharmaceutical and/or medical device 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.

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. - Ensure CDISC/SDTM datasets and define documents are appropriately prepared for submission. - Assist in defending strategy and findings to FDA

Qualifications
- 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, adaptive clinical trials, and/or analysis of correlated data preferred. SAS programming in a pharmaceutical/clinical environment. Proficiency in Base SAS and SAS stat modules.

Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes

Status Full-Time


Nearest Major Market: Rochester


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