Paid / North America / Full-time
• We are developing R tools for clinical trial safety analysis. These include tools for generating SDTM/ADaM datasets and presentation-ready table/listing/figure. Applications are primarily to support internal safety review but also to support submission activities.
• The ideal candidate for this role is expected to be proficient in using R to manipulate/analyze data and wrap them as R functions . In addition, the candidate needs to have strong knowledge of Base SAS and SAS Macros in order to leverage the existing SAS scripts.
• Uses R programming to generate summary tables, data listings, graphs and derived SDTM/ADaM datasets as specified in the statistical analysis plan and programming specifications.
• Provide R programming support within multiple studies/projects in various study activities with timely and high-quality programming results as assigned tasks and projects.
• Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Bachelor or Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field.
• 1+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
• Able to develop R function.
• Strong hands-on experience with R (e.g., Tidyverse, ggplot2, admiral, gt, reactable, etc.)
• Strong Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
• Strong knowledge of ICH guidelines.
• Solid understanding & implementation of CDISC requirement for regulatory submissions.
• Experience working with cross-functional teams.
• Effective communication.
Please send your resume to email@example.com if you would like to apply.