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Biostatistics Job USA | Senior Manager position @ Kite Pharma

Biostatistics Job USA | Senior Manager position @ Kite Pharma

Biostatistics Job USA | Senior Manager position @ Kite Pharma: Kite Pharma is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.  Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.  We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.

Biostatistics Job USA | Senior Manager position @ Kite Pharma

Responsibilities:

  • Provides statistical expertise and input to drug development programs and safety surveillance including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value
  • Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies
  • Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.  Authors technical reports and publications, ensures the timely delivery of top line study results
  • Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses
  • Ability and experience to work with safety to develop appropriate tools and analysis strategies for safety surveillance
  • Monitors project progress and ensures proper resource allocation; performs vendor oversight for assigned programs and provides quality review of vendor deliverables
  • Establishes and maintains effective working relationships with vendors and project teams
  • Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology; maintains currency with developments in these fields
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks

Requirements:

  • MS or PhD in biostatistics, statistics, or mathematics
  • 6+ years experience in biostatistics in clinical development and drug development experience in oncology
  • Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development
  • Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results
  • Working knowledge of SAS and / or R

Biostatistics Job USA | Senior Manager position @ Kite Pharma

Kite Pharma, an equal opportunity employer. We are able to offer the upside of working in a small, but growing company where everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commiserate to any large corporation. To learn more about us, please visit our website at www.kitepharma.com

Job Posted date: 7 Sept,2016

How to apply  & View Original Notification: https://careers.jobscore.com/careers/kitepharma/jobs/senior-manager-biostatistics-cNvPP0mZir5RgzdG1ZS6tF

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