Job Summary (Primary function)
The Assoc Dir, Biostatistics is responsible for providing statistical support to drug development programs.
Essential Functions of the Job (Key responsibilities)
- Participate in the development and enforcement of SOPs and guidelines.
- Participate in regulatory activities such as health authority meetings and submission related activities.
- Participate and contribute to authoring of Clinical Development Plan.
- Assist in writing relevant sections of the clinical study report.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Provide guidance and supervision to team members in authoring of analysis dataset specifications and programming of tables, listings, and figures.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Write and review statistical analysis plans.
- Provide statistical input to study protocols.
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Manage and develop a diverse team of statisticians.
- Provide strategic input to drug development and the development of the biometrics department.
- Serve as a member of the biometrics management team, to manage and support drug development in Incyte.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- 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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