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Principal Biostatistician

Principal Biostatistician

IncyteWilmington, DE, United States
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Overview

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 Principal Biostatistician is responsible for providing statistical support for drug development programs in all phases of development.

Essential Functions of the Job (Key responsibilities)

  • Participate in the development and enforcement of SOPs and guidelines.
  • Participate in pre-IND and NDA 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 support to team members in creating analysis dataset specifications and programming of tables, listings, and figures.
  • Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
  • Write statistical analysis plans.
  • Interact with members of the multidisciplinary project teams to establish project timelines. Provide statistical input to study protocols.

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Familiarity with multivariate analyses and biomarker analyses is beneficial.
  • Experience in collaborating with health authorities, including discussions and negotiations in filing strategies, is highly desirable.
  • Proficiency in using SAS to perform efficacy analyses and validate important data derivations when necessary.
  • Able to effectively communicate their ideas and to manage team members in a constructive manner.
  • Demonstrate ability to work independently and collaboratively in project management and decision making.
  • Experience in pharmaceutical / biotechnology industries and a broad knowledge of biostatistics is preferred, but not required. We welcome candidates with diverse backgrounds and experiences.
  • Advanced degree in statistics or equivalent experience preferred.
  • 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.

    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.

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    Biostatistician • Wilmington, DE, United States

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