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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.
*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.
*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.