BrightOwl Loader Loading

Senior, Principal Biostatistican / Manager, Biostatsistics - United States  

Company managed [?] Still accepting applications

Posted on : 02 June 2017

Project Description

Description:
This position is responsible for providing statistical support to drug development programs.

 

Summary of the Essential Functions of the Job 
  • Provide statistical input to study protocols 
  • Develop statistical analysis plan 
  • Monitor internal and CRO project activities including timelines, deliverables and   availability of resources 
  • Interpret study results and write (or at least QC and review) statistical summary reports of study results 
  • Assist in writing relevant sections of the clinical study report 
  • Participate and contribute to Clinical Development Plan 
  • Participate in pre-IND and NDA activities 



Minimum Requirements
  • Ph.D. degree in statistics  
  • Industry internships to to eight years of experience in pharmaceutical or biotechnology industries with broad knowledge of biostatistics. 
  • For the Sr. manager position, a good understanding of FDA/EMEA guidelines and drug development process is required.  
  • Demonstrated ability to work independently in project management and decision making 
  • 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 
  • Be able to effectively communicate his/her ideas and be able to manage programmers in a constructive manner to make other people more effective. 
  • Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
  • This requirement may be waived for research oriented statisticians with demonstrated capabilities of developing and implementing new statistical methods.