Senior Director, Biostatistics

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 Senior Director, Biostatistics leads the Biostatistics team within therapeutic areas of Incyte and responsible for providing statistical input to development strategies, and effective implementation plans to support product development in a global organization. The Senior Director provides expertise and guidance in collaboration with cross-functional groups across the organization in establishing study design and analyses and strategy, and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance and management to statisticians to ensure high quality and timely deliverables.

Essential Functions of the Job (Key responsibilities)

* Lead the Biostatistics team within therapeutic areas of Incyte and is responsible for providing statistical input to development strategies, and effective implementation plans to support product development or market access objectives in a global organization.

* Direct and guide statisticians to ensure high quality and timely deliverables.

* Provide expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing study design and analyses and strategy, and institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies.

* 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.

* Key contributor to Clinical Development Plans, submissions, and post-submission strategies, preparation etc.

* Represent the company in interfaces with regulatory agencies globally.

* Compliant with Incyte processes and SOPs, adherence to global and project standard.

* Drive strategy for processes improvement, contributes to new departmental SOPs, and provide training on statistical topics and departmental SOPs.

* Participate in industry-wide technical discussions and represent company in professional societies.

* Anticipate potential issues and take preventive measures; identify and oversee the resolution for the team.

* Enable culture of inclusiveness, respect for diversity, compliance with process and allow for the questioning and challenging of others in a respectful and constructive manner.

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

* Ph.D. degree in statistics or biostatistics.

* Minimum 10 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.

* Experience in oncology or IAI drug development, from Phase I to Phase III.

* Demonstrate ability to work independently in project management and decision making.

* Excellent interpersonal, communication, writing and organizational skills and excellent collaboration, organizational/ leadership abilities.

* Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation

* Extensive experience in preparing and participating in global regulatory agency interactions

* Experience managing and developing other statisticians.

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.