Associate Director, Biostatistics
Company: Incyte Corporation
Location: Wilmington
Posted on: October 31, 2025
|
|
|
Job Description:
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) 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. Incyte Corporation is committed to
creating a diverse environment and is proud to be an equal
opportunity employer. The Incyte hiring organization processes your
personal data to manage your job application in order to enter into
an employment relationship with you if you are the successful
candidate. During the process, you may be asked to respond to
questions that will screen out your application if you do not meet
certain objective criteria required by the job. You may have the
right to access, delete, restrict, edit, move, or object to the use
of your personal data. You may also have a right to report concerns
to the authority responsible for data privacy in the country where
the position is based or where you live or work. By accessing this
link you can learn about the types of personal data we collect, how
we use it, whether collection and processing is optional, sources
of the personal data we process, how it is shared, where it is
stored or transferred to, how long we keep it, and contact
information for Incyte, Incyte’s data protection officer, and your
supervisory authority (if applicable).
Keywords: Incyte Corporation, Wilmington , Associate Director, Biostatistics, Science, Research & Development , Wilmington, Delaware