Principal Statistician – Centralised Statistical Monitoring - Gaithersburg, MD | Biospace
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Principal Statistician – Centralised Statistical Monitoring

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Cambridge, England, United Kingdom
Gaithersburg, Maryland, United States
Gothenburg, Västra Götaland, Sweden
Job reference: R-000377

Posted date: Jan. 17, 2017



   Principal Statistician – Centralised Statistical Monitoring  

   Salary: Competitive  

   Location: - UK or Sweden  

   We are currently recruiting for a principal statistician to join our growing Statistical Innovation team within our Advanced Analytics Centre (AAC). The Statistical Innovation group is an expert team providing consultancy, capability build and training across a range of clinical statistics areas, including trial design, subgroups, missing data, safety analysis, data exploration & mining, economic modelling and observational research.  

   The AAC provides high-end methodological and analytical support to the AstraZeneca drug development organisation, and is a genuinely novel, innovative, exciting and challenging place to work. The four AAC skill groups are:  

  •      Statistical Innovation    
  •      Scientific Computing Solutions    
  •      Biomedical Informatics    
  •      Health Informatics    

   This role is a specialist assignment within Statistical Innovation, which will focus on the Centralised Statistical Monitoring (CSM) in large, multi-site clinical trials. CSM is an integral part of Risk Based Monitoring (RBM) and involves running sophisticated statistical analyses in order to detect data integrity issues. It represents a unique opportunity for a motivated and collaborative scientific statistician to help us build a new evolving area within the Pharmaceutical Industry and AstraZeneca.  

   Main Duties and Responsibilities  

   In consultation with clinical study teams, you will develop the CSM strategy and plans for individual trials. You will carry out CSM at defined points in the trial and report on findings to the study statistician and study team and carry out further investigations on potential data integrity issues. You will lead the development and implementation of new statistical methods for CSM and RBM and collaborate with study teams to understand importance of different variables, critical-to-quality factors and key risk indicators. You will need to interact with the external vendor who are providing CSM tools to AstraZeneca and work closely with the AZ Centralised Monitoring group, including provision of training and guidance.  

   Essential Experience  

  •      Experience of clinical drug development    
  •      Understanding of CSM and RBM, and their impact on study conduct & integrity    
  •      Experience of advanced innovative statistical techniques for CSM      
    •          Identification and understanding of the implications of missing data in this context        
    •          Predictive modelling to generate expected values/distributions        
    •          Interpretation of extreme/outlying data in the context of multiplicity        
    •          Identification of univariate and multivariate outliers and their impact on data integrity.        
    •          Identification of unusual patterns in data.        
    •          Graphical techniques for data appraisal        
  •      Broad/general knowledge of statistical methods and their application to clinical/medical data    
  •      Statistical software & programming: JMP/Clinical, R, SAS    

   Desirable experience:  

  •      Oncology, ImmunoOncology, Respiratory, Inflammation & autoimmunity, Cardiovascular diseases, Diabetes & Metabolic diseases    

   An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability.  


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