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29 Jun → 29 Jul
Dickinson, ND 58601, USA
Working within the Clinical Operations Department and Programming/Biostats functional unit, the Programmer Analyst is responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans. This position is also responsible for a number of other activities related to the creation of statistical outputs for a clinical trial.
- Follow departmental SOPs and guidelines
- Assure Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Ensured completeness, accuracy, and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies while following Good Clinical Practices (GCP) and FDA’s validation rules for submission datasets and SDTM IG 3.2.
- Works with data management to identify issues in data quality
- Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks
- Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management
- Work independently to carry out assignments with occasional support from senior management
- Contribute to the ongoing improvement of programming processes and methodology
- Review closely CRF annotations and data specifications
- Develop programming specifications based upon the study protocol and statistical analysis plan (SAP)
- Apply CDISC standards for SDTM and ADaM specifications when applicable
- Create persistent SAS datasets and table, figure, and listing outputs (TFLs) according to study specifications and Statistical Analysis Plan (SAP)
- Perform validation programming for all programming deliverables
- Develop SAS macros and utility programs for repeat use across projects
Requirements / Qualifications
- Bachelor’s degree (or higher) in Statistics, Computer Science, or another closely related field to programming
- Base SAS certification or the equivalent SAS programming experience, ideally in clinical trials and/or within a CRO context.
- 2+ years SAS programming preferred
- Ability to communicate well in written and spoken English
- A commitment to working within a team and producing high-quality results while working under timeline constraints.
How To Apply
Apply through GoRemotely.