STATISTICIAN (Non-Clinical) Senior Principal

for a major division of a worldwide pharmaceutical company engaged in the
research, development, manufacturing and marketing of ethical
pharmaceuticals, consumer/OTC  and vaccines products.
 
LOCATION:  Northeast
 
COMPENSATION:  Negotiable in 6 figures + relocation + full fringe benefit
package.
 
The Senior Principal Statistician will play a key role in expanding and
broadening the scope of statistics in quality control and manufacturing of
vaccine products and will provide guidance in problem-solving efforts,
support on FDA regulatory issues and to assist in management decision
making.
 
Provide statistical consulting for process improvement in manufacturing and
laboratory testing for marketed products. 
 
Plan and develop efficient and practicable statistical designs and analyses
concerned with stability data, formulations research, i.e. batch failures,
assay development, process validation, specifications development, sampling
plans, regulatory data and vendor qualification studies.  
 
Ensure that all programs are in compliance with FDA requirements and ICH
guidelines. 
 
Interact extensively with personnel in manufacturing, quality control,
research and technical services. 
 
Develop and administer training courses on statistical methods in order to
increase statistical thinking and awareness among company personnel.
 
 
REQUIREMENTS: 
 
M.S. or Ph.D. in Statistics 
 
Knowledge of the theory and techniques of applied statistical methods.  
 
Knowledge of linear models, regression, variance component analysis and
laboratory related statistical tools. 
 
Strong computer skills including a working knowledge with software packages
such as  SAS, S-PLUS, etc. 
 
Effective oral and written communication skills; and interpersonal skills.
Pharmaceutical industry experience is preferred. 

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