Associate Director, Biostatistics

  • Incyte Corporation
  • Morges, VD, Switzerland
  • 08/03/2021
Full time Data Science Data Engineering Data Analytics Big Data Statistics Biostatistician

Job Description

Summary

The Assoc Dir, Biostatistics is responsible for providing statistical support to drug development programs.

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.

Requirements

  • 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.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

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 can learn more about this process here.

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.

You can learn more about Incyte’s data protection practices here. 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).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights