Director Biostatistician

Overview

• Lead statistical strategies for oncology clinical trials, ensuring robust methodologies and regulatory compliance across all phases.
• Collaborate with multidisciplinary teams to design studies, establish standards, and oversee data collection and reporting processes.
• Provide expert statistical guidance to anticipate challenges, mitigate risks, and ensure successful project outcomes.
• Represent biostatistics in interactions with regulatory agencies, ethics committees, and institutional review boards.
• Develop and implement departmental policies, standards, and practices in coordination with leadership.
• Manage timelines, deliverables, and budgets for contract research organizations and external vendors.
• Contribute to the development of proposals and evaluation of clinical trial designs.
• Ensure statistical oversight within assigned therapeutic areas, focusing on oncology trials.

Key Responsibilities & Duties

• Develop and implement statistical designs and analyses for clinical trials, ensuring robust methodologies and regulatory compliance.
• 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 and validation 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, including contract research organizations, ensuring quality deliverables and adherence to budgets.
• Guide the completion of major programs by implementing appropriate statistical techniques and criteria.
• Collaborate with other disciplines such as data management, clinical operations, and regulatory affairs.

Job Requirements

• PhD in Statistics/Biostatistics or related field with at least 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 FSPs and CROs, 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.