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Fortrea

Senior Statistical Programmer

Posted 6 Days Ago
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In-Office or Remote
Hiring Remotely in San Jose, CA, USA
Senior level
In-Office or Remote
Hiring Remotely in San Jose, CA, USA
Senior level
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.
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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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