Statistical Programmer Sr
Core
Senior Statistical Programmer developing, validating, and delivering high-quality statistical programming outputs (SDTM, ADaM, TLFs) for regulatory submissions in clinical drug development.
Role type
Senior IC Statistical Programmer (Clinical Trials)
Builds
Submission-ready datasets, analysis datasets, safety and efficacy tables, listings, figures, and Define.xml packages for FDA, PMDA, and EMA.
Domain
Pharmaceutical/Biotechnology, Clinical Drug Development, Regulatory Submissions
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS (Base, STAT, Macro), CDISC standards (SDTM, ADaM), Clinical Trial Methodologies, Regulatory Guidelines (E6, E3, E9, 21 CFR Part 11), Data Automation, R Programming, Git Version Control
Preferred skills
AI tools for programming efficiency, NDA filing preparation, Relational databases, Shell scripting
Technologies
SAS, R (tidyverse, dplyr, admiral, rtables, ggplot2, xportr, flextable), Git (GitHub, GitLab), Define.xml, Pinnacle 21
Responsibilities
Develop specifications and SAS programs for SDTM and ADaM datasets; Create and validate Tables, Listings, and Graphs (TLGs) based on SAPs; Design and maintain reusable SAS macros for Phase I–IV trials; Generate submission-ready datasets compliant with industry standards; Collaborate with cross-functional teams to ensure timely delivery; Convert SAS programs to R using AI tools.
Seniority
Senior, hands-on IC