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Advanced/Senior Biostatistician


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 www.agilent.com.


We are currently seeking an experienced Biostatistician with medical device background for our Dako North America office in Carpinteria, CA to work within the field of Companion Diagnostics.


Responsibilities/Deliverables:


Prepares statistical analysis plans and writes detailed specifications for analysis methods.


Interprets analyses and writes statistical sections of study protocols and reports.


Supports teams in the planning, design, conduct, and reporting of studies, as well as in regulatory submissions, to meet project objectives, including internal/external validation, and clinical studies.


Collaborates with pharmaceutical partners in support of clinical development projects and presentations/publications.


Communicates with the FDA regarding statistical analysis issues. Provides technical and strategic support in resolving issues.


Required Skills:


Strong knowledge of statistical (theoretical) principles and applied statistics.


Experience with statistical software such as R, S-Plus, and SAS.


Good understanding of molecular biology, cancer, immunology, genetics or genomics in addition to standard molecular assays and technologies.


Ability to create study specifications and provide support in the review of data management documentation.


Stays up-to-date on new developments in statistics, molecular technology, drug development and regulatory guidance through literature review, industry workshops, etc.



 

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