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Senior Statistical Programmer


As a Statistical Programmer you will be involved in one or more clinical development programs spanning all phases of Clinical Research and your assignments would involve:

  • supporting Global Submissions to FDA, EMA and PMDA (and other regulatory authorities)
  • supporting key pivotal trials in late development compounds
  • creating integrated efficacy/safety summaries and other submission related documents
  • preparing analyses to support preparations for Advisory committees (ODAC and AdCom)
  • supporting HAQs as and when needed


  • University/Bachelors Degree or Equivalent
  • At least 5 years previous clinical programming experience
  • Proven experience in development of advanced MACROs.
  • Working experience in pooling analysis datasets across multiple clinical studies (or equivalent).
  • Demonstrated skills in developing data sets and TFLs in line with sponsor specifications.
  • Working knowledge of database design/structures and basic statistics.
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
  • Strong knowledge of / experience with SAS and other relevant programming software.
  • Working knowledge of CDISC data standards including ADaM and SDTM.
  • Fluent English (oral and written).


Degrees of interest: Medicine - Healthcare, Sciences

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