Principal Biostatistician

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $96.5k - $191.5k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Assist in designing studies and preparing statistical analysis plans • Analyze pharmacokinetic, clinical, and pre-clinical study data • Interpret statistical results from pharmacokinetic, clinical, and related analyses • Generate randomization schedules for clinical studies • Contribute to scientific literature and Worldwide Clinical Trials’ intellectual property • Lead interdisciplinary project teams • Perform project management and solve technical problems using contemporary methods • Support clinic, method development, and marketing/business development through literature reviews and related expertise • Train and guide less experienced personnel • Supervise personnel involved in statistical and pharmacokinetic-related work • Design clinical studies and construct data analysis plans • Perform statistical analyses using appropriate methods and software • Prepare final-report documentation, including text, tables, graphs, and analysis outputs • Interact with clients, bioanalytical personnel, and clinical personnel regarding study design, statistical analyses, pharmacokinetic data analyses, and data interpretation • Identify quality problems or potential problems, report concerns, and propose solutions • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree with a scientific focus and 12 or more years of relevant work experience required • PhD or postgraduate degree with a scientific focus preferred • Familiarity with corporate policies, goals, and objectives, normally acquired after three months of exposure to Worldwide Clinical Trials’ operations • Understanding and application of Good Laboratory Practice (GLP) guidelines and U.S. Food and Drug Administration (FDA) guidance documents pertinent to statistical analysis, pharmacokinetic studies, pharmacokinetic analyses, and reports • Excellent SAS programming skills • Proficiency in WinNonlin, nQuery, Microsoft Word, and Microsoft Excel • Ability to read, write, and understand complex literature • Ability to write concise, understandable study reports and communicate clearly with clients and Worldwide Clinical Trials personnel • Ability to create, understand, and interpret graphs, tables, and charts • Strong organizational and problem-solving skills and ability to set priorities • Ability to interact effectively with superiors, peers, and others and communicate ideas clearly • Ability to follow and implement Worldwide Clinical Trials’ policies and Standard Operating Procedures, normally associated with three months of experience at Worldwide Clinical Trials

🏖️ Benefits

• Competitive benefits package depending on location • Transparent compensation and pay equity