Senior Statistical Programmer/Analyst Consultant (Need solid oncology background) Remote in US

Overview

Senior Statistical Programmer Consultant working directly for a single sponsor through ClinChoice, leading statistical programming for oncology clinical trials.

What you'll do

• Lead statistical programming activities for clinical studies within the oncology therapeutic area, from study start-up through database lock, analysis, and reporting.
• Develop, review, and maintain high-quality SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs).
• Lead programming activities for interim and final analyses, including complex efficacy and safety analyses.
• Work closely with Biostatisticians to understand statistical analysis plans, programming specifications, and study requirements.
• Develop and review programming specifications and ensure consistency with study protocols, SAPs, and statistical methodology.
• Support the creation and validation of CDISC-compliant SDTM and ADaM datasets.
• Generate and validate TLFs for clinical study reports, regulatory submissions, and other clinical deliverables.
• Perform independent programming validation and quality control of statistical outputs and datasets.
• Support submission-related activities and respond to programming and data-related queries from cross-functional and regulatory teams.
• Identify potential programming issues and proactively communicate risks, timelines, and solutions to project stakeholders.
• Coordinate programming activities across studies and ensure deliverables are completed within agreed timelines and quality standards.
• Provide technical guidance and mentorship to Statistical Programmers and other programming team members.
• Participate in client/project meetings and effectively communicate technical information to both technical and non-technical stakeholders.

What you'll need

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.
• Strong experience in clinical trial statistical programming, preferably within a CRO, pharmaceutical, or biotechnology environment.
• Significant experience working on oncology clinical trials.
• Experience supporting regulatory submissions.
• Strong proficiency in SAS programming, including Base SAS and relevant SAS procedures used for clinical trial reporting.
• Strong knowledge of CDISC standards, particularly SDTM and ADaM.
• Experience developing and validating TLFs for clinical trials.
• Experience working with complex clinical trial data and supporting statistical analyses.
• Ability to independently manage programming deliverables and lead study-level programming activities.
• Strong understanding of clinical development processes, including protocols, SAPs, datasets, TLFs, and clinical study reports.
• Excellent communication, organizational, problem-solving, and collaboration skills.

Nice to have

• Basic or working knowledge of R programming.

Details

• Remote in the United States.
• Contract role.
• Client-facing role requiring the ability to work independently.