Associate Director Biostatistician

Overview

• Drive statistical design and analysis for oncology clinical trials, ensuring methodological rigor and impactful results.
• Collaborate with cross-functional teams to align statistical strategies with clinical and regulatory objectives.
• Apply advanced statistical techniques to optimize trial protocols and data interpretation.
• Lead statistical programming efforts, ensuring compliance with industry standards and guidelines.
• Contribute to innovative solutions for complex statistical challenges in oncology research.
• Support regulatory submissions with validated statistical analysis and comprehensive documentation.
• Enhance trial outcomes through expertise in early-phase oncology clinical trials.
• Collaborate on publications and presentations to showcase statistical insights and trial results.

Key Responsibilities & Duties

• Develop and review clinical protocols, statistical analysis plans, and data specifications.
• Perform statistical analyses and interpret study results for regulatory submissions and publications.
• Manage external vendors to ensure high-quality deliverables within timelines and budgets.
• Oversee programming of analysis datasets, tables, listings, and figures.
• Ensure adherence to regulatory guidelines and industry standards in statistical practices.
• Collaborate with multidisciplinary teams to align statistical strategies with clinical objectives.
• Contribute to the development of submission deliverables and validation processes.
• Provide statistical expertise in oncology and early-phase clinical trial design.

Job Requirements

• Doctorate in Biostatistics or related field with minimum 5 years of experience.
• Proficiency in SAS programming and statistical applications for clinical trials.
• Experience in oncology and Phases I-III clinical trials preferred.
• Strong knowledge of regulatory guidelines and industry standards.
• Ability to manage CROs and ensure quality deliverables within timelines.
• Expertise in developing/reviewing SDTM/ADaM specifications.
• Excellent analytical and communication skills for multidisciplinary collaboration.
• Capacity to lead statistical aspects of multiple concurrent studies.
• Familiarity with clinical data management procedures and statistical methodologies.