Associate Director, Biostatistics

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🔥 0 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Director

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👻 Ghost score 25%

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Lead statistical activities for assigned clinical trials, mainly Phase 3, independently from protocol design to reporting of results • Represent the Statistics function on cross-functional trial teams • Oversee internal programming activities and/or CRO contributions • Contribute to or lead database lock and submission activities, safety reporting, ad hoc requests, and responses to regulatory questions • Collaborate with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements • Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses • Coordinate statistical activities across studies within the assigned project to ensure aligned objectives, consistent approaches, and on-time delivery • Formulate integrated analytical approaches, mine data sources, and use statistical, machine learning, and deep learning methods to discover actionable insights and automate repeated processes

🎯 Requirements

• Master’s degree in Statistics or related quantitative discipline; PhD preferred • 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry • Solid recent experience (≥3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review • Strong knowledge of adaptive design, group sequential and statistical methods of count data • Prior experience on Hematology studies preferred • Good understanding of the drug development process and cross-functional interfaces • Experience supporting end-to-end trial delivery, from protocol input through CSR contributions • Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions • Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams • Excellent and effective communication skills; ability to interact effectively with cross-functional stakeholders and external partners • Strong organizational and project management skills • Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables

🏖️ Benefits

• Consistent training, development and support • Significant professional growth opportunities