- Perform the role of the Lead Statistical Programmer.
- Develop and maintain SAS programs to create complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
- Develop and/or lead the development of complex specifications for SDTMs and ADaM
datasets and contribute to the development of Covance and Client standards
- Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
- Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs
ensuring adherence to department practices and processes
- Respond to QA and client audits and support qualification audits
- Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health
science, or related subjects.
- Experience and/or education plus relevant work experience, equating to a Bachelor's
- Typically 6 years of SAS® programming experience in the CRO or Pharmaceutical
industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Experience as lead statistical programmer on complex studies in clinical research
- Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
- Broad knowledge of all CDISC requirements related to SDTM and ADaM, including
define.xml, Reviewer's Guide and submission standards
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