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 Phase I–IV clinical trials independently from protocol design through reporting of results • Represent the Statistics function on cross-functional trial, indication, or project teams • Collaborate with cross-functional stakeholders • Oversee internal programming activities and/or CRO contributions • Contribute to or lead statistical activities including safety reporting, ISS/ISE, Health Authority questions, and publications • Use SAS and/or R for dataset and deliverable QC, inferential statistical analyses, modelling/simulation, and exploratory analyses • Participate in initiatives at Cytel or the sponsor side • Oversee more junior statisticians as required • Provide statistical and development support for clinical trials, processes, clinical development plans, concept sheets, and protocols • Formulate integrated analytical approaches using data sources, statistical methods, machine learning, and deep learning algorithms

🎯 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 and demonstrate initiative and flexibility through effective, innovative leadership • Attention to detail and quality focus • Excellent interpersonal and communication skills • Innovative and collaborative behaviours • SAS programming skills for QCing critical outputs, efficacy/safety tables, and collaboration with programmers • Knowledge of R programming, R Shiny, or Python • Clear technical understanding of proper clinical-trial data analysis, including the ICH E9 guideline • Experience representing the biostatistics function and collaborating cross-functionally • Strong communication skills • Willingness to self-learn and perform duties with minimum guidance

🏖️ Benefits

• Consistent training, development and support • Significant professional growth opportunities • Working fully embedded with support from Cytel • Autonomy and ownership