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 eCRFs and
Reviewers Guides to support SDTMs and ADaMs
With support from senior programming staff, develop specifications for SDTMs and ADaM
Review SAPs and TFL shells from a programming perspective for studies with support from
senior programming staff
Respond to QA and client audits with support from senior programming staff
With sufficient experience assume the role of a Lead Statistical Programmer for CP studies
only with support from senior programming staff.
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.
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 degree
- Typically 1 - 2 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
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