Principal Biostatistician, FSP

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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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 (Phases 1 to 4) independently from protocol design to reporting of results • Represent Statistics function on cross-functional trial and possibly indication/project teams • Collaborate with cross-functional stakeholders • Oversee internal programming activities and/or CRO contributions on assigned clinical trials • Contribute to or lead statistical activities including Safety Reporting, ISS/ISE, Health Authority questions, and Publications • Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses • Contribute to and participate in initiatives at Cytel or sponsor side • Oversee more junior Statisticians as needed • Provide statistical and development support for client trials, including processes, clinical development plans, concept sheets, and protocols • Formulate integrated analytical approaches to mine data sources, apply statistical methods and machine learning/deep learning algorithms, discover actionable insights, and automate repeatable processes

🎯 Requirements

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a Master’s degree with a minimum of 6 years relevant work experience • Ability to work independently and demonstrate initiative and flexibility through effective and innovative leadership • Attention to detail and quality-focused approach • Excellent interpersonal and communication skills • Innovative and collaborative behaviours • SAS programming skills for QCing critical outputs and Efficacy/Safety tables • Ability to work closely with Programmers

🏖️ Benefits

• Consistent training, development and support • Significant professional growth • Work with autonomy and ownership • Support of Cytel while fully embedded with a pharmaceutical client