
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.
🔥 17 hours ago
🌐 United Kingdom, United States – Remote
⏰ Full Time
🟠 Senior
🇬🇧 UK Skilled Worker Visa Sponsor
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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.
• Independently manage statistical project support and provide expert statistical consultancy • Manage statistics support for projects or sponsor programs of work • Review study designs, analysis plans, and reports • Assist sponsors with clinical trial design, protocols, randomization methodology, and statistical analysis plans • Consult with internal departments, sponsors, and third parties on statistical issues and reporting requirements • Specify and review tables, figures, and listings shells • Write and review derived dataset specifications • Prepare final reports, including tables, listings, figures, and report writing • Develop, evaluate, run, and validate SAS programs for clinical study data analysis and reporting • Maintain program descriptions, validation documentation, and other required documentation • Produce ad hoc data summaries and extract trial information from systems • Validate software and test SAS macros • Contribute statistical content to manuscripts for publication and presentation • Support bidding through budget review, proposals, and bid defense meetings • Lead system and process improvements for clinical study data processing and reporting • Support development of statistical design and analysis policies • Assist with quality assurance and audit requirements • Assist the Director of Biostatistics with other aspects of the role • Perform activities in compliance with company, sponsor, ICH, FDA, and 21 CFR Part 11 standards • Perform other duties as assigned
• Computer literate and numerate, with ability to adapt to various computer systems • Expert-level project statistician experienced in providing statistical leadership to projects • Design and analysis consultancy skills across a broad range of applications • Customer focus, delivering on commitments, building strong relationships, communicating, influencing, and embracing innovation and change • Master's level in mathematics, statistics, or another subject with a strong statistical component • Minimum 3 years of statistical experience leading clinical trial projects and data analysis • Knowledge of statistical software packages such as SAS and nQuery • Knowledge of regulatory guidance documents, including ICH, FDA, and CPMP • Ability to comply with relevant quality standards, including FDA Quality System Regulation and 21 CFR Part 11
• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Exceptional employee experiences
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