About The Position
ClinChoice is seeking an experienced Principal Statistical Programmer Consultant to work directly with a client and provide programming expertise and leadership for clinical development programs, primarily focused on solid tumor oncology studies. The role supports clinical programming deliverables across Phase I–III trials and requires independent work and the ability to establish a high-trust environment with client counterparts. The consultant will lead statistical programming activities, develop and validate CDISC-compliant SDTM and ADaM datasets, and program and review complex tables, figures, and listings for clinical study reports and regulatory submissions. The role also supports oncology efficacy and safety analyses, collaborates with biostatistics and cross-functional teams, provides technical oversight and mentorship, and contributes to regulatory submissions and process improvements.
Requirements
- Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline.
- Extensive clinical statistical programming experience in the pharmaceutical or biotechnology industry.
- Strong hands-on SAS programming experience, including SAS Base, SAS Macro, and SAS/STAT.
- Significant experience supporting solid tumor oncology clinical trials, preferably across Phase I, II, and III studies.
- Strong knowledge of oncology efficacy endpoints, including Overall Survival, Progression-Free Survival, Objective Response Rate, and Duration of Response.
- Expertise in CDISC SDTM and ADaM standards.
- Experience developing and validating complex tables, figures, and listings for clinical study reports and regulatory submissions.
- Knowledge of ICH-GCP and FDA/EMA regulatory requirements.
- Excellent communication, problem-solving, and cross-functional collaboration skills.
Nice To Haves
- Experience with immuno-oncology and targeted cancer therapies.
- Exposure to clinical trials involving head and neck, lung, colorectal, breast, or other solid tumor indications.
- Experience with FDA or EMA regulatory submissions.
- Prior experience providing technical leadership and mentoring statistical programming teams.
Responsibilities
- Lead and oversee statistical programming activities for oncology clinical trials, primarily in solid tumor indications.
- Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards.
- Program and review complex tables, figures, and listings for clinical study reports and regulatory submissions.
- Support oncology efficacy and safety analyses, including Overall Survival, Progression-Free Survival, Objective Response Rate, Duration of Response, and Disease Control Rate.
- Apply Kaplan-Meier analysis, Cox proportional hazards models, and other time-to-event analyses.
- Collaborate with biostatisticians, data management, clinical teams, and cross-functional stakeholders to ensure timely, high-quality deliverables.
- Provide technical leadership, programming oversight, and mentorship to statistical programmers.
- Review programming specifications, analysis datasets, and statistical outputs for accuracy and consistency.
- Support regulatory submissions and respond to health authority requests as needed.
- Identify opportunities to improve programming standards, processes, and efficiencies.
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What This Job Offers
Career Level
Principal
