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The Principal Statistical Programmer Consultant leads programming for oncology trials, ensuring programming quality and regulatory compliance while collaborating with various teams and managing timelines.

Provide statistical leadership for oncology Phase I-III trials: develop SAPs/protocols/CSRs, design efficacy and safety analyses, oversee SDTM/ADaM datasets and TLFs, support interim/DMC and adaptive analyses, contribute to regulatory submissions, and mentor junior statisticians.

Lead and support statistical programming deliverables for clinical studies: implement protocol programming, ensure high-quality outputs and documentation, write/implement specifications, enforce standards and compliance, contribute best practices, manage tasks, communicate risks, and collaborate with statisticians, data managers, and study leads.

Lead statistical strategy and deliverables for Immunology clinical trials. Author and review SAPs, ADS, and clinical study report sections; review analysis outputs; collaborate with Clinical, Programming, Data Management, and Regulatory teams; mentor programmers; ensure FDA/ICH/GCP compliance.

Lead statistical design and analysis for late-phase oncology studies, including protocol development, sample size, SAPs, oversight of data quality, tables/figures, mentoring statisticians, and coordinating project deliverables while ensuring regulatory compliance.

Develop and validate SDTM and ADaM datasets using R following CDISC standards; support TLF generation, QC checks, regulatory deliverables, automation and R-based pipelines; collaborate with statisticians, data managers, and clinical teams.

Client-facing data scientist supporting clinical data transfer, ETL, validation, analysis, and Power BI dashboards. Build R scripts, assist data harmonization, support internal tools and basic web interfaces while working with cross-functional teams on clinical trial data.

Lead statistical programming strategy and teams for clinical studies, oversee development/validation of SDTM/ADaM datasets and TLFs, ensure regulatory submission readiness (eCTD), drive SAS/R workflows, automation, and cross-functional collaboration with biostatistics, data management, and regulatory teams.

The Associate Director/Director Biostatistician leads statistical strategy for clinical trials, ensuring compliance with regulatory standards and collaborating with cross-functional teams on project deliverables.