About this role
Summary of Responsibilities:
• 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 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.
Physical Demands/Work Environment:
• Office or home-based environment, as requested by the line manager. • Travel Requirements: Yes. • Local, Domestic, Regional. • % of time: Approximately 5%. • % of the above that requires overnight stay: Approximately up to 100%. • Travel is primarily to where: client meetings and trainings.
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