Principal Biostatistician – Inhouse Project

Job not on LinkedIn

🔥 18 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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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 provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas • Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables • Author and review Statistical Analysis Plans (SAPs), Analysis Database Specifications (ADS), and statistical sections of clinical study reports • Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance • Collaborate with Clinical, Programming, Data Management, and Regulatory teams • Provide guidance and oversight to statistical programmers as needed • Communicate statistical concepts, results, and risks to technical and non-technical stakeholders • Ensure adherence to FDA, ICH, GCP, and company SOPs

🎯 Requirements

• MS or PhD in Statistics, Biostatistics, or a related field • Strong experience in Oncology studies • Hands-on experience writing Statistical Analysis Plans (SAPs) • Hands-on experience writing Analysis Database Specifications • Experience reviewing and interpreting analysis results • SAS programming skills required (hands-on or strong working knowledge) • Excellent written and verbal communication skills • Experience working in a CRO and/or pharmaceutical/biotech environment • Experience leading Phase II–III clinical trials (preferred) • Prior interaction with regulatory agencies (preferred) • Experience mentoring junior statisticians or programmers (preferred)

🏖️ Benefits

• Professional growth opportunities • Fulfilling and rewarding career • Continuous training and development • Equal opportunity and diversity and inclusivity culture

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