03 ธันวาคม 2562
รหัสงาน: BK-163363
Statistician / Senior Statistician

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

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

รายละเอียดงาน:

GreenLight Clinical (Thailand) Co., Ltd.
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