Senior Statistician

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Posted 2 months ago

Senior Statistician

Reports to: Head of Biostatistics

Why you’re here 

You will provide statistical expertise on projects and therapeutic areas. For one or more projects, you will be responsible for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory requirements, and scientific validity. You will be a key statistical consultant within the company, with regional or global project responsibilities. 

What you’ll deliver 
  • Study design and sample size
  • Statistical contribution to clinical study protocols
  • Statistical review of electronic Case Report Forms (eCRF)
  • Statistical Analysis Plans (SAP)
  • Table, listing, and figure (TLF) shells
  • Statistical review of output
  • Statistical review of the Clinical Study Report (CSR)
How we’ll measure it
  • Regulatory acceptance of statistical output and trial results
  • Observed adequacy of sample sizes at the end of trials
  • Ability of non-specialists to understand explanations of statistical output
  • Ability to identify errors in statistical output
  • Appropriateness of proposed study designs for achieving relevant scientific and commercial goals
What you’re responsible for
  • Representing statistics at internal project meetings
  • Ensuring collaboration and knowledge sharing. 
  • Learning and applying advanced statistical techniques 
  • Scientifically valid statistical analysis of clinical trial data 
  • Liaising with statistical programmers to ensure appropriate ADaM datasets
Qualifications
  • Postgraduate degree in statistics
Work experience
  • Pharmaceutical or CRO experience or other experience with clinical trials or biomedical research
Technical knowledge & skills or other requirements
  • Knowledge and understanding of advanced statistical concepts and techniques
  • High level of SAS or R programming
  • Knowledge of clinical trial methodology
  • Understanding of the regulatory drug submission/approval process regionally and globally

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