Principal Biostatistician, FSP

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🔥 0 minutes ago

🌐 India, South Africa – Remote

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⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 25%

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Logo of Clinical Outcomes Solutions

Clinical Outcomes Solutions

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 effectively with all cross-functional stakeholders. • Oversee internal programming activities and/or CRO contributions on assigned clinical trials. • Contribute to or lead Safety Reporting, ISS/ISE, responses to 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 initiatives at Cytel or sponsor side. • Provide oversight of more junior Statisticians. • Formulate integrated analytical approaches using statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate recurring processes.

🎯 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 • Autonomy and ownership in work • Support from Cytel while embedded with a pharmaceutical client

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