at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
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)
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.
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.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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