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 the tidyverse family of packages while adhering to production-quality standards. In addition, the candidate needs to have strong knowledge of Base SAS and SAS Macros in order to leverage the SAS outputs.
Role responsibilities:
- 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.
Qualifications:
- 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 communicator.