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).
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