Senior Statistical Programmer (R programming)

Job Title: Senior Statistical Programmer (Oncology)\nLocation: Canada/IN\nEmployment Type: Full-Time\nExperience: 8+\n\nOverview\nWe 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.\n\nCore Responsibilities\nProgram, validate, and maintain clinical trial datasets and outputs using SAS and R.\nDevelop and review statistical outputs using R packages such as tidyverse (dplyr, tidyr), , haven, readr, ggplot2, survival, lubridate, and RMarkdown/knitr (as applicable).\nLead and execute the full spectrum of statistical programming deliverables, including:\nCreation and review of SDTM and ADaM specifications\nDevelopment of SDTM and ADaM datasets\nTLF (Tables, Listings, Figures) programming\nPreparation of Define.xml and reviewer’s guides\nDevelop, enhance, and maintain macros to support study and project requirements.\nWork independently with minimal oversight, ensuring timely and high-quality deliverables.\nDemonstrate a strong sense of ownership and accountability for assigned tasks.\nCommunicate proactively with internal teams, providing clear updates and technical guidance.\nIdentify opportunities for process improvements and contribute suggestions to strengthen team efficiency.\nSupport Oncology clinical trials, including understanding of oncology-specific standards and endpoints such as RECIST, ORR, PFS, OS, DoR, and time-to-event analyses.\nWork with oncology data structures including tumor assessments, lesion-level data, and response evaluations (where applicable).\nParticipate actively in programming meetings, cross-functional discussions, and knowledge-sharing sessions.