The Assoc Dir, Biostatistics is responsible for providing statistical support to drug development programs.
- Serve as a member of the biometrics management team, to manage and support drug development in Incyte.
- Provide strategic input to drug development and the development of the biometrics department.
- Manage and develop statisticians.
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Provide statistical input to study protocols.
- Write and review statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Provide guidance and supervision to statisticians and programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Assist in writing relevant sections of the clinical study report.
- Participate and contribute to authoring of Clinical Development Plan.
- Participate in regulatory activities such as health authority meetings and submission related activities.
- Participate in the development and enforcement of SOPs and guidelines.
- Ph.D. degree in statistics with 7-9 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
- Experience in oncology drug development, from Phase I to Phase III.
- Demonstrated ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
- Knowledge of multivariate analyses and Biomarker analyses is a plus.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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