Senior Principal Biostatistician

2 weeks ago


Wilmington, Delaware, United States Incyte Full time

Job Summary

The Senior Principal Biostatistician is responsible for providing statistical support to drug development programs at Incyte, a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines.

Key Responsibilities

  • Interact with multidisciplinary project teams to establish project timelines and provide statistical input to study protocols.
  • Write statistical analysis plans and monitor internal and CRO project activities, including timelines, deliverables, and availability of resources.
  • Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming tables, listings, and figures.
  • Interpret study results and review statistical summary reports for accuracy.
  • Assist in writing relevant sections of the clinical study report and participate in the development and enforcement of SOPs and guidelines.

Qualifications

  • Ph.D. degree in statistics required.
  • 5 to 8 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
  • Demonstrate ability to work independently in project management and decision making.
  • Able to effectively communicate ideas and manage programmers in a constructive manner.
  • Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.


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