Director Biostatistician

Overview

• Lead statistical methodologies for oncology clinical trials, ensuring compliance with regulatory standards and robust study designs.
• Collaborate with cross-functional teams to design studies and oversee data collection and analysis processes.
• Provide expert guidance on statistical challenges, mitigating risks to ensure successful trial outcomes.
• Represent biostatistics in regulatory and ethical discussions, ensuring alignment with industry standards.
• Develop and implement departmental policies and practices in collaboration with leadership.
• Manage timelines, deliverables, and budgets for external vendors and contract research organizations.
• Contribute to clinical trial proposals and evaluate study designs for oncology research.
• Ensure statistical oversight within therapeutic areas, focusing on innovative oncology trials.

Key Responsibilities & Duties

• Develop and implement statistical designs and analyses for oncology clinical trials, ensuring compliance with regulatory standards.
• Review protocols, case report forms, and statistical analysis plans for clinical studies.
• Perform statistical analyses, interpret results, and collaborate with clinical teams to produce reports and publications.
• Direct the development of integrated safety and efficacy summaries for regulatory submissions.
• Engage with regulatory authorities to ensure agreement on project development and compliance.
• Evaluate and manage external vendors, ensuring quality deliverables and adherence to budgets.
• Guide the completion of major programs by implementing appropriate statistical techniques and criteria.
• Collaborate with data management, clinical operations, and regulatory affairs teams to ensure seamless project execution.

Job Requirements

• PhD in Statistics, Biostatistics, or related field with 10+ years of relevant experience.
• Extensive experience in statistical design and analysis for oncology clinical trials, preferably solid tumor studies.
• Proficiency in statistical software such as SAS, R, EAST, and nQuery.
• In-depth knowledge of CDISC standards and FDA/EU statistical guidelines.
• Experience managing external vendors, including project management and contract negotiation.
• Strong communication skills and ability to collaborate across multidisciplinary teams.
• Proven track record in leading Phase III clinical trials and regulatory submissions.
• Ability to work onsite five days a week, with relocation support available.