Role & responsibilities
Perform statistical programming activities for clinical trials across various phases, with a strong focus on Oncology studies.
Develop, program, review, and validate Tables, Listings, and Figures (TLFs) using SAS and R.
Create and maintain SDTM and ADaM datasets in accordance with CDISC standards.
Perform programming for efficacy and safety analyses.
Work on Oncology-specific endpoints and analyses including:
Progression-Free Survival (PFS)
Overall Survival (OS)
Objective Response Rate (ORR)
Duration of Response (DOR)
Time-to-event / survival analyses
Kaplan-Meier analyses
Demonstrate hands-on programming experience in both SAS and R on live clinical studies.
Develop production-quality programs and perform programming checks, validation, and QC.
Support statistical programmers and biostatisticians in the development and review of analysis datasets and TLFs.
Work closely with Biostatistics, Clinical Data Management, Data Standards, Medical Writing, and other cross-functional teams.
Support preparation of statistical programming deliverables for Clinical Study Reports (CSR).
Contribute to regulatory submission-related programming and documentation for agencies such as FDA/EMA, where applicable.
Review specifications, programming requirements, analysis plans, and study documentation.
Troubleshoot programming issues and ensure timely delivery of high-quality study outputs.
Preferred candidate profile
7+ years of relevant experience in Clinical Statistical Programming.
Robust hands-on expertise in SAS and R.
Strong experience in Oncology clinical trials.
Robust knowledge of CDISC standards SDTM and ADaM.
Hands-on experience in TLF programming.
Good understanding of clinical trial data and statistical analysis concepts.
Experience with efficacy and safety programming.
Knowledge of survival analysis / time-to-event analysis.
Experience with Oncology endpoints such as PFS, OS, ORR and DOR will be highly preferred.
Experience in validation/QC and regulatory submission programming is desirable.
Robust analytical, problem-solving, communication, and stakeholder-management skills.