Essential Job Duties:
? Perform the role of the Lead Statistical Programmer
o 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
? Typically 3-5 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
? Knowledge of CDISC requirements
Education/Qualifications/Certifications and Licenses
? 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
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