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 and pharmaceutical experience to conceive and develop 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. This position can be located in Rochester, NY or Madison, NJ.
Specific Job Duties:
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.
- Collaborate on protocol development including study design, endpoint selection, and power and sample size assessment.
- Review 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.
- Write and oversee implementation of statistical analysis plans for multiple studies, creating summary templates and specifications.
- Write/review statistical and outcome sections of study reports and submissions.
- Assess feasibility of analysis requests and associated timelines. Develop efficient budgets and assess budget impact of proposed changes. Communicate/discuss data/analysis issues with internal project teams as well as CROs.
- Ensure CDISC/SDTM datasets and define documents are appropriately prepared for submission.
- Participate in team communication/discussion with regulatory agencies
Bausch + Lomb is an Equal Opportunity Employer.
- PhD in statistics or biostatistics with 5+ years of experience or MS with 8+ years of experience in applied statistics, preferably clinical trial experience.
- Demonstrated ability to lead multiple projects in a fast paced environment.
- Proven ability to lead a team of statisticians and/or SAS programmers to efficient production of accurate and timely deliverables.
- Experiences in managing timelines and budgets for multiple projects within the context of larger study teams.
- Solid understanding of regulatory requirements and guidance documents
- Sound knowledge of statistical theory and application in the pharmaceutical/biotech industry.
- Excellent written and oral communication.
- Good programming skills in SAS and/or R.
United States-New Jersey-Madison Site
Bausch + Lomb - 6 months ago
Bausch & Lomb Inc. is a global eye health company that develops, manufactures and sells contact lenses and lens care products, ophthalmi...