Well established international contract research organization serving both commercial as well as government markets, is conducting a search for a SAS Programmer.
- Responsible for converting datasets to SDTM standards.
- Designs ADaM datasets and variables.
- Experienced in writing SDTM specifications and annotations.
- Serve as mentor to other developers with less CDISC expertise.
- Map and convert raw clinical data sets to CDISC SDTM compatible data sets.
- Validate CDISC SDTM and ADaM data sets by using Open-CDISC Validation Tool.
- Create data definition documents for CDISC SDTM and ADaM datasets and other electronic submission components.
- Produce tables, listings, and figures for the clinical study report (CSR).
- Convert legacy clinical trials data to CDISC data format.
- Manage time effectively. Accurately estimate effort for tasks and meet agreed-upon deadlines. Effectively manage ad-hoc requests and multiple deadlines. Identify opportunities for automation, improved efficiency and reuse.
- Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. Respond promptly to requests from Validation/Test team for documentation or bug fixed.
Bachelor’s degree in a related field and 4+ years CDISC, SDTM and ADaM experience required inclusive of creating derived data sets. Must have strong SAS programming skills and solid working knowledge of CDISC standards. Experience in the CRO and/or pharmaceutical industry is preferred. Knowledge of database mapping tools and experience with biostatics in clinical trials are highly preferred as well.