Senior Statistical Programmer (R programming)

princeps technologies (india, India) Follow 12 hours ago

Full-time Clinical Trials SAS Oncology Datasets Macro

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Job Title: Senior Statistical Programmer (Oncology)

Location: Canada/IN

Employment Type: Full-Time

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 datasets
TLF (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.