Senior Biostatistician

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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

• Manage statistical support for one or more projects or sponsor programs • Provide expert review of study designs, analysis plans, and reports • Assist sponsors with clinical trial design, protocol statistical sections, randomization methodology, and statistical analysis plans • Liaise with internal departments, sponsors, and third parties on statistical issues and reporting requirements • Specify and review tables, figures, listings shells, derived dataset specifications, report documents, and tabulations • Prepare final reports, including tables, listings, figures, and report writing • Develop, test, run, and validate SAS programs for clinical study statistical analysis and reporting • Maintain program and validation documentation • Produce ad hoc data summaries and extract trial information from systems • Validate software and test SAS macros • Contribute statistical content to manuscripts and presentations • Support bidding activities, including budget reviews, proposals, and bid defense meetings • Lead system and process improvements for clinical study data processing and reporting • Support statistical design and analysis policies • Maintain knowledge of statistical methodologies, software packages, and regulatory guidance • Assist with quality assurance and audit requirements • Support the Director of Biostatistics as required • Perform activities in compliance with WCT, sponsor quality systems, ICH standards, FDA Quality System Regulation, and 21 CFR Part 11 • Perform other assigned duties

🎯 Requirements

• Degree-level education in mathematics, statistics, or another subject with a strong statistical component • Computer literacy and numeracy • Proven ability to adapt to various computer systems • Hands-on expert-level project statistician experience • Experience providing statistical leadership to projects • Design and analysis consultancy skills across a broad range of applications • Knowledge of statistical software packages such as SAS and nQuery • Knowledge of regulatory guidance documents, including ICH, FDA, and CPMP points to consider • Ability to work independently • Competence in customer focus, delivering on commitments, relationship building, communication and influencing, and embracing innovation and change

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Exceptional employee experiences • Collaboration and creativity-focused workplace