Title: Biostatistician

Location:New
Jersey

Start: November 2009

Duration: 3 Months

Opportunity Overview:

Responsible for providing project leadership in Biostatistics for one or more
specific company products or a therapeutic area as assigned.

Main Responsibilities:

• 
  
  Responsible for providing project leadership in Biostatistics
  for one or more specific company products or a therapeutic area as
  assigned.
  
  
• 
  
  You will participate in the development of standards across
  protocols in protocol development, analysis plans and file/report
  specifications.
  
  
• 
  
  Review CRFs and data edits as well as review forms for
  statistical analyses, interprets statistical results, and prepares clinical
  study reports including integrated summaries for submissions.
  
  
• 
  
  Reviews analysis of other study statisticians participating
  on their project for accuracy, consistency, and quality output.
  
• 
  

Requirements:

• 
  
  MS or PhD in Biostatistics/Statistics and equivalent MS with
  6 or PhD with 4 years or more working on clinical trials Conversant with SAS
  programming, and detailed knowledge of SAS procedures and other statistical
  software
  
  
• 
  
  Past interaction with FDA BLA/NDA experience desired but not
  essential
  
  
• 
  
  Thorough understanding of statistical principles and clinical
  trial methodology with the ability to practice and implement them Able to write
  and present information effectively.
  
  
• 
  
  Working knowledge of regulatory guidelines relating to
  statistical analysis, study reports and statistical components of regulatory
  submissions
  
  
• 
  
  Effective communicator: able to explain methodology and
  consequences of decisions in lay terms; able to understand requests for complex
  analyses, etc.
  
  
• 
  
  Effective team player; willingness to go the extra distance
  to get results, meet deadlines, etc.
  
  
• 
  
  Able to manage many projects simultaneously, to manage
  conflicting priorities, and to be flexible when priorities change. Must be able
  to deal with ambiguity
• 
  

Industry Specific Experience (Company):
Pharmaceutical/Biotechnology

Years of Experience: 7-10 Years