Clinical Research

• Serves as a statistical department resource
• Prepares Statistical Analysis Plans (SAPs)
• Collaborates with sponsors
• Directs the activities of other biostatistics personnel
• Conducts and participates in verification and quality control of project deliverables

Principal Biostatistician – Future Roles

• Manage day-to-day biostatistics activities
• Serve as lead biostatistician for programs of studies, submissions, or individual studies
• Oversee statistical activities that support ICON's interactions with clients and regulatory agencies
• Review and approve statistical methods sections of study protocols
• Prepare and approve research proposals and budgets
• Participate in bid defense meetings and make presentations at marketing meetings with prospective clients

Principal Biostatistician

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes
• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
• Build and manage strong relationships with trial investigators and stakeholders
• Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

Clinical Trial Manager

• Oversee clinical trials, ensuring successful execution from start-up to close-out.
• Lead site selection and feasibility assessments, working closely with CRAs and investigators.
• Manage study timelines, budgets, and deliverables, ensuring adherence to project objectives.
• Provide oversight on protocol administration, site initiation, monitoring, and study progress.
• Collaborate cross-functionally with internal and external stakeholders, including sponsors, investigators, and project teams.
• Ensure compliance with GCP, FDA regulations, and company SOPs.
• Train and mentor CRAs and site staff, ensuring protocol adherence and data integrity.

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Principal Biostatistician – Future Roles

Principal Biostatistician

Clinical Trial Manager

Clinical Lead – Clinical Trial Manager, Renal