Senior Statistical Programmer (R programming)
Job Title: Senior Statistical Programmer (Oncology)
Location: USA/Canada
Employment Type: Contract
Experience: 8+Overview
We are seeking an experienced Senior Statistical Programmer with strong Oncology clinical trial experience to support end-to-end clinical programming activities. This role requires strong technical proficiency, autonomy, and the ability to collaborate effectively within cross-functional and global teams. The ideal candidate will have hands-on experience supporting oncology indications, oncology endpoints, and regulatory submission deliverables.
Core Responsibilities:
Program, validate, and maintain clinical trial datasets and outputs using SAS and R.Develop and review statistical outputs using R packages such as tidyverse (dplyr, tidyr), data.table, haven, readr, ggplot2, survival, lubridate, and RMarkdown/knitr (as applicable).Lead and execute the full spectrum of statistical programming deliverables, including:
- Creation and review of SDTM and ADaM specifications
- Development of SDTM and ADaM datasetsTLF (Tables, Listings, Figures) programming
- Preparation of Define.xml and reviewer’s guides
- Develop, enhance, and maintain macros to support study and project requirements.
- Work independently with minimal oversight, ensuring timely and high-quality deliverables.
- Demonstrate a strong sense of ownership and accountability for assigned tasks.
- Communicate proactively with internal teams, providing clear updates and technical guidance.
- Identify opportunities for process improvements and contribute suggestions to strengthen team efficiency.
- Support Oncology clinical trials, including understanding of oncology-specific standards and endpoints such as RECIST, ORR, PFS, OS, DoR, and time-to-event analyses.
- Work with oncology data structures including tumor assessments, lesion-level data, and response evaluations (where applicable).Participate actively in programming meetings, cross-functional discussions, and knowledge-sharing sessions.