- 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.
- Strong hands-on expertise in SAS and R.
- Robust experience in Oncology clinical trials.
- Strong 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.
- Strong analytical, problem-solving, communication, and stakeholder-management skills.