Summary of Responsibilities:
- 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.
- 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 Reviews Guides to support SDTMs and ADaMs.
- With support from senior programming staff, develop specifications for SDTMs and ADaM datasets.
- 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.
- And 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, 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.
Physical Demands/Work Environment:
- Office or home-based environment, as requested by the line manager.
- Travel Requirements:
- 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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