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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), , 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 reviewers 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. 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), , 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 reviewers 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.
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