- Perform the role of the Lead Statistical Programmer
- Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs
- Develop specifications for SDTMs and ADaM datasets
- Review SAPs and TFL shells from a programming perspective for studies
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
- Present and share knowledge at department meetings
- Respond to QA and client audits, and support qualification audits
- Identify processes within programming that will increase productivity, quality and efficiency
Bachelor or Master degree in computers or healthcare.
5 to 8 years of relevant experience in SDTM, ADaM, TFL
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