Lead and oversee statistical programming for clinical studies: develop and QC SAS programs to produce SDTM/ADaM datasets and TFLs, create Define-XML/ARM/annotated CRFs, review SAP/TFL shells, mentor junior programmers, interact with clients and QA, and improve programming processes.
Summary of Responsibilities:
- Perform the role of the Senior 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 Reviews 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.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- 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.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Language Skills Required: Speaking: Yes, English required Writing/Reading: Yes, English required
Experience (Minimum Required):
- 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.
Learn more about our EEO & Accommodations request here.
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