AD Biostatistician

Overview

• Lead statistical support for oncology clinical trials, ensuring robust design and analysis methodologies.
• Collaborate with multidisciplinary teams to develop protocols, statistical analysis plans, and study reports.
• Apply advanced statistical techniques to analyze clinical data and interpret results.
• Manage external vendors to ensure quality deliverables within timelines and budgets.
• Contribute to regulatory submissions by ensuring compliance with guidelines and standards.
• Provide expertise in oncology trials, focusing on solid tumor studies and Phase III research.
• Utilize SAS, R, and EAST software for statistical programming and data analysis.
• Support the client’s mission to advance oncology treatments through innovative clinical research.

Key Responsibilities & Duties

• Develop and review clinical trial protocols, CRFs, and statistical analysis plans.
• Perform statistical analyses and collaborate on the interpretation of study results.
• Author statistical sections of clinical study reports and publications.
• Manage CROs to ensure adherence to project timelines and quality standards.
• Oversee programming and validation of ADaMs and TLFs for clinical studies.
• Ensure compliance with regulatory guidelines and industry standards.
• Participate in multidisciplinary meetings, representing biostatistics and clinical data management.
• Provide statistical expertise in oncology, with a focus on solid tumor Phase III trials.

Job Requirements

• Doctorate in Statistics, Biostatistics, or related field with 5+ years of experience.
• Extensive experience in oncology clinical trials, particularly Phase III studies.
• Proficiency in SAS, R, and EAST for statistical programming and analysis.
• Strong knowledge of regulatory guidelines and clinical trial standards.
• Experience managing CROs and external vendors for clinical research projects.
• Ability to work onsite five days a week and relocate if necessary.
• Excellent communication skills and ability to collaborate with multidisciplinary teams.
• Commitment to advancing oncology treatments through innovative research.