Statistical Programmer II
Role Overview
Experienced Statistical Programmer with expertise in supporting multiple clinical studies through the development, validation, and delivery of high-quality statistical programming outputs.
Proficient in SAS (Base SAS, SAS/STAT, and Macro Language) and CDISC standards, including SDTM, ADaM, and TLF development for regulatory submissions.
Skilled in creating analysis datasets, safety and efficacy tables, listings, figures, Define.xml, and submission packages compliant with FDA, PMDA, and EMA requirements.
Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle 21 validation.
Proven ability to collaborate with internal stakeholders, proactively resolve programming issues, and ensure timely, compliant, and accurate study deliverables.
Use of R and AI tools to augment, enhance day to day programming is a huge plus.
Key Skills for This Role
Full Job Posting
Technical Skills
- ➢ Advanced SAS programming expertise in data extraction, integration, analysis, reporting, and automation. ➢ Proficient in Base SAS, PROC SQL, Macro Programming, ODS, SAS/GRAPH, SAS/STAT, SAS/CONNECT, and SAS/ACCESS. ➢ Extensive experience with SAS reporting procedures, including PROC SQL, PROC REPORT, PROC SUMMARY / PROC Means, PROC FREQ, and PROC TRANSPOSE, in clinical research environments. ➢ Skilled in working with relational databases, SAS performance optimization, and process automation through batch, shell scripting and AI tools. ➢ Experienced in R programming (tidyverse, dplyr, admiral, rtables ggplot2, xportr, flextable) and Git-based version control (GitHub, GitLab). ➢ Experienced in developing Tables, Listings, and Graphs (TLGs) using SAS and R for clinical trial analysis and reporting.
About eClinical Solutions
eClinical Solutions provides a cloud-based clinical data management and analytics platform that helps life sciences companies streamline clinical trials and accelerate drug development.
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