Senior Principal Biostatistician
2 weeks ago
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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