Principal Statistical Programmer Consultant – Oncology, Solid Tumors

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🇺🇸 United States – Remote

⏳ Contract/Temporary

🔴 Lead

🖥 Software Engineer

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• Lead and oversee statistical programming activities for oncology clinical trials, primarily focused on 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 • Perform Kaplan-Meier analysis, Cox proportional hazards models, and other time-to-event analyses • Collaborate with biostatisticians, data management, clinical teams, and cross-functional stakeholders • 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 • Improve programming standards, processes, and efficiencies

🎯 Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline • Extensive experience in clinical statistical programming within the pharmaceutical or biotechnology industry • Strong hands-on experience with SAS programming, 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 OS, PFS, ORR, and DoR • Expertise in CDISC SDTM and ADaM standards • Experience developing and validating complex TFLs for clinical study reports and regulatory submissions • Knowledge of ICH-GCP and regulatory requirements (FDA/EMA) • Excellent communication, problem-solving, and cross-functional collaboration skills • 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

🏖️ Benefits

• Professional development • Supportive culture • Continuous training • Close management and training • Career opportunities through working for a global CRO • Client-facing role with a high-trust environment

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