Associate Director, Biostatistics, R&D

Job Description

You will join a growing oncology-focused Data Sciences function and serve as the lead statistician for one or more oncology development programs, providing statistical leadership across Phase I–III clinical trials. This role is responsible for developing and executing statistical strategies that support study design, regulatory submissions, data interpretation, and key development decisions throughout the clinical development lifecycle.

The role is based in Cambridge (MA), US or Cambridge, UK and reports to Head of Biostatistics.

• Serve as the lead statistician for late-stage oncology studies, including Phase III registrational trials, providing statistical leadership from protocol development through submission and post-submission activities.
• Contribute to clinical development strategies, study designs, endpoint selection, and evidence-generation plans as a core member of cross-functional program teams.
• Lead the development and review of protocols, statistical analysis plans (SAPs), clinical study reports, and other key study documents.
• Ensure delivery of high-quality biostatistics deliverables for assigned studies and programs in alignment with timeline, quality, and regulatory expectations.
• Lead statistical contributions to regulatory submissions (e.g., NDA/BLA/MAA) and health authority interactions.
• Contribute to the development and implementation of statistical methodologies, standards, and best practices that support consistent and high-quality study execution.
• Represent Biostatistics on cross-functional program teams, study governance meetings, and scientific collaborations.
• Advance the application of advanced and innovative statistical approaches (e.g. Bayesian and adaptive statistical methods).
• Evaluate and apply AI-enabled analytics, automation, and advanced decision-support capabilities to enhance statistical efficiency, evidence generation, and decision-making for assigned development programs.

• PhD or MSc in Statistics, Biostatistics, or a related field (PhD preferred).
• 10+ years of experience in clinical drug development, oncology preferred.
• Demonstrated experience serving as lead statistician for late-stage oncology clinical trials, including Phase III studies and regulatory submissions.
• Extensive regulatory experience (FDA, EMA, ICH), including leading or contributing to multiple marketing submissions.
• Deep expertise in oncology; experience in IO and/or ADC is a strong advantage.
• Strong command of advanced statistical approaches (e.g. Bayesian and adaptive designs) and their application in oncology.
• Excellent leadership, strategic-thinking, collaboration, and communication skills.
• Understanding of AI-assisted statistical workflows and emerging technologies applicable to drug development and evidence generation.

The expected annual salary range for this position is USD 130,000–300,000 for U.S.

-based candidates, depending on skills, experience, and job-related qualifications. For UK-based candidates, compensation will be aligned with Orion’s salary range for the applicable grade.