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Senior Biostatistician

Company: Agilent
Location: Santa Clara
Posted on: February 23, 2021

Job Description:

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at . Come and join us in a highly collaborative environment where we fight cancer together! You will be part of our Companion Diagnostics group, supporting various teams as a statistical SME on several exciting CDx assay development projects. In addition to working with our diverse cross-functional Agilent team, you will be collaborating with our partner statisticians on the pharmaceutical side, to support the design of clinical trial studies that use companion diagnostic tests, as well as with the FDA and other regulatory bodies, to ensure that submissions are complete and meeting all requirements. More directly, you will be joining our Biostatistics team, which is a team of four statisticians overseen by a manager. As Senior Biostatistician, you will also have the opportunity to mentor more junior members on the team! The Senior Biostatistician supports statistical needs across all projects in the Companion Diagnostics group, as needed. Key responsibilities:

  • Provides guidance to pharma partners on clinical trial studies and CDx assay development activities
  • Participates in communications with the FDA in pre-subs, submissions and deficiency letters
  • Supports internal teams in assay development activities, including design and statistical analysis
  • Prepares statistical analysis plans and writes detailed specifications for analysis methods
  • Analyzes data, interprets results and writes statistical sections of study protocols and reports
  • Mentors more junior team members This is a remote position on the West Coast - provided by Dice

Keywords: Agilent, Santa Clara , Senior Biostatistician, Other , Santa Clara, California

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