Principal Statistician

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

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👻 Ghost score 10%

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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 • Act as 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 for 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 SOP standards

🎯 Requirements

• MS or PhD in Statistics, Biostatistics, or a related field • No specific therapeutic area requirements; experience in Oncology, Rare Disease, or Neuroscience is advantageous • Strong oral and written communication skills • Understanding of statistics, the drug development process, and relevant FDA regulations • Pharmaceutical, CRO, or related industry experience with clinical trials • Experience interacting with Regulatory Agencies, especially the FDA

🏖️ Benefits

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