Principal Biostatistician

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

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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 (Phases 1 to 4) independently from protocol design to reporting of results. • Represent Statistics function on cross-functional trial and possibly indication/project teams and collaborate with all cross-functional stakeholders. • Provide oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities. • Contribute to or lead statistical activities including Safety Reporting, ISS/ISE, addressing questions from Health Authorities, 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 other initiatives at Cytel or sponsor side. • Provide oversight of more junior Statisticians as required. • Work fully embedded within one pharmaceutical client as part of a sponsor-dedicated program.

🎯 Requirements

• Minimum of Bachelor's degree in statistics or a related discipline. • 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership. • Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours • SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. • Knowledge of R programming (R Shiny/Python)

🏖️ Benefits

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