Manager, Statistical Programming Consultant – Oncology

🔥 20 hours ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🔴 Lead

💼 Consultant

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 across Phase I, II, and III oncology clinical trials • Manage, mentor, and provide technical guidance to statistical programmers • Oversee development, validation, and delivery of SDTM and ADaM datasets and Tables, Listings, and Figures (TFLs) • Ensure accurate implementation of Statistical Analysis Plans (SAPs) and oncology-specific endpoints, including OS, PFS, ORR, and DoR • Provide programming oversight for survival analysis, Kaplan-Meier curves, and RECIST 1.1-based tumor response assessments • Collaborate with Biostatistics, Data Management, and other cross-functional teams • Manage project timelines, resource allocation, and programming deliverables • Ensure compliance with CDISC standards, FDA/EMA requirements, and applicable regulatory guidelines

🎯 Requirements

• Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related discipline • 8+ years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry • Prior experience in a managerial, team lead, or programming lead role • Strong hands-on expertise in SAS programming • Extensive experience supporting oncology clinical trials, particularly solid tumor studies • Strong knowledge of CDISC standards, SDTM, ADaM, and TFL development • Experience with oncology endpoints, survival analysis, and RECIST 1.1 • Proven ability to lead programming teams and manage multiple clinical study deliverables

🏖️ Benefits

• Professional development • Supportive culture • Continuous training • Close management and training • Equal opportunity and diversity/inclusivity commitment

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