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Title:Director Biostatistics, Oncology
Salary:Open
Experience:8+
Location:NJ - Northern

Description:

Director Biostatistics, Oncology

Responsibilities:
  • Oversees, reviews and /or executes the timely completion of high quality biostatistics deliverables for Clinical Development Plans, PCs/Protocols, Statistical Analysis Plans, Monitoring, Clinical Study Reports and Regulatory interactions for multiple studies, often as the compound lead.
  • May participate in PCS Reviews and Protocol Reviews providing Biostatistics comments and input.
  • Develops strategic plans for regulatory submissions.
  • Oversees preparation of inputs for regulatory documents for own studies.
  • Represents Eisai at Health Authority meetings.
  • Manages preparation of responses to Health of responses to Health Authorities for own studies.

Requirements:
  • At least 8 years of pharmaceutical clinical trial experience (oncology experience preferred) with Ph.D. in biostatistics or statistics.
  • Experience in clinical development biostatistics methods and processes in industry setting required.

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