Statistician

Overview

• Serve as a Statistician in clinical development, focusing on statistical analysis for Phase II-III trials.
• Utilize advanced statistical methods to support study designs and data analysis.
• Collaborate remotely with multidisciplinary teams to ensure statistical integrity.
• Contribute to Statistical Analysis Plan (SAP) creation and data lock processes.
• Apply knowledge of CDISC standards in clinical trial data management.
• Provide oversight and guidance on statistical programming deliverables.
• Develop and implement quantitative methods for clinical trial evaluations.
• Ensure compliance with regulatory requirements and industry standards.

Key Responsibilities & Duties

• Design and execute statistical analyses for Phase II-III clinical trials.
• Create and review Statistical Analysis Plans (SAPs) and oversee data locks.
• Collaborate with cross-functional teams to ensure statistical accuracy.
• Provide expertise in CDISC standards for clinical trial data management.
• Oversee statistical programming deliverables and ensure quality outputs.
• Develop innovative statistical methods for clinical study evaluations.
• Ensure compliance with regulatory standards and statistical guidelines.
• Communicate statistical findings effectively to stakeholders.

Job Requirements

• Master’s degree in Statistics, Biostatistics, or a related quantitative field.
• Minimum of 4 years of experience in clinical development, Phase II-III trials.
• Proficiency in statistical programming and application of quantitative methods.
• Experience with CDISC standards and clinical trial data management.
• Strong oral and written communication skills for effective collaboration.
• Ability to create and manage Statistical Analysis Plans (SAPs).
• Knowledge of regulatory requirements and statistical guidelines.
• Capability to work remotely and manage deliverables effectively.