Senior Statistical Programmer Consultant (Oncology)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Statistical Programmer Consultant (Oncology) based in United States.

This role plays a key part in the execution and oversight of oncology clinical trial programming activities across multiple studies within a highly regulated pharmaceutical environment. You will be responsible for delivering high-quality statistical programming outputs that support regulatory submissions, clinical analyses, and study reporting. Acting as a senior technical expert, you will develop and validate CDISC-compliant datasets while ensuring accuracy, traceability, and consistency across all deliverables. The position involves close collaboration with biostatistics, data management, regulatory, and clinical teams, as well as external CRO partners. You will also contribute to study leadership, helping manage timelines, resolve complex programming challenges, and support integrated analyses. This is a high-impact role suited for an experienced programmer who thrives in oncology-focused environments and enjoys both technical depth and cross-functional leadership.

This role is responsible for leading statistical programming activities for oncology clinical trials, ensuring high-quality CDISC-compliant datasets, analysis outputs, and regulatory-ready deliverables while coordinating cross-functional and vendor collaboration.

• Lead end-to-end statistical programming for oncology studies, including SDTM and ADaM dataset development in compliance with CDISC standards.
• Produce and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
• Ensure traceability, accuracy, and quality control across all programming deliverables and analysis datasets.
• Collaborate with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs teams to support study execution and submissions.
• Oversee and coordinate with CROs and external vendors to ensure adherence to programming standards and timelines.
• Support integrated analyses such as ISS and ISE, as well as responses to regulatory queries and data requests.

Requirements:

This position requires extensive experience in statistical programming within pharmaceutical or CRO environments, with strong expertise in SAS, CDISC standards, and oncology clinical trials.

• 8–12+ years of statistical programming experience in pharma, biotech, or CRO settings.
• Expert-level proficiency in SAS programming, with strong familiarity with R preferred.
• Deep understanding of CDISC standards, including SDTM and ADaM implementation.
• Significant experience supporting oncology clinical trials, including hematologic or solid tumor studies.
• Proven experience preparing regulatory submission packages and submission-ready outputs.
• Strong cross-functional communication skills and ability to collaborate with scientific and regulatory teams.
• Ability to manage multiple studies, timelines, and deliverables in a fast-paced environment.
• Experience with clinical data analysis, derivations, and complex dataset programming.

Benefits:

• Competitive compensation aligned with experience
• Opportunity to work on high-impact oncology clinical trials
• Remote and flexible working arrangements
• Exposure to global regulatory submission projects
• Collaborative, science-driven working environment
• Professional growth in advanced statistical programming and clinical research
• Engagement with leading experts across biostatistics, data management, and regulatory functions