Principal Biostatistician Consultant – Oncology

🕒 May 28

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III). • Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs). • Design and review statistical methodologies for efficacy and safety analyses. • Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards. • Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs. • Collaborate with clinical development, data management, programming, regulatory, and medical teams. • Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA). • Provide strategic input on study design, endpoint selection, and sample size calculations. • Mentor junior statisticians and provide technical guidance.

🎯 Requirements

• PhD or MS in Statistics, Biostatistics, or related field. • 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics. • Strong experience in oncology clinical trials. • Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs. • Proficiency in SAS and/or R. • Strong knowledge of CDISC standards (SDTM, ADaM). • Experience supporting regulatory submissions. • Excellent communication and leadership skills.

🏖️ Benefits

• Health insurance • professional development opportunities