Senior Principal Biostatistician

2 weeks ago


Wilmington, Delaware, United States Incyte Full time
Job Summary

The Senior Principal Biostatistician is a key member of our drug development team, responsible for providing statistical support to our programs.

Key Responsibilities
  • Collaborate with cross-functional teams to establish project timelines and provide statistical input to study protocols.
  • Develop and implement statistical analysis plans, ensuring accuracy and reliability of results.
  • Monitor project activities, including timelines, deliverables, and resource availability.
  • 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.
  • Contribute to the development of clinical study reports and participate in pre-IND and NDA activities.
  • Develop and enforce SOPs and guidelines, ensuring compliance with regulatory requirements.
Qualifications
  • Ph.D. degree in statistics required.
  • 5-8 years of experience in pharmaceutical/biotechnology industries, with a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
  • Proven ability to work independently in project management and decision-making.
  • Effective communication and leadership skills, with the ability to manage programmers in a constructive manner.
  • Proficiency in SAS and experience with multivariate analyses and biomarker analyses are highly desirable.


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