This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Biostatistics based in the United States. As an Associate Director of Biostatistics, you will provide strategic statistical leadership across clinical development programs focused on innovative cancer therapies. You will lead the design, execution, and interpretation of clinical trial analyses, supporting programs from early-stage dose optimization through pivotal studies and regulatory submissions. Working closely with clinical development, statistical programming, data management, and regulatory teams, you will ensure that statistical strategies deliver reliable, high-quality evidence to guide critical decisions. You will also contribute to interactions with global health authorities and help maintain the integrity of clinical data throughout the development lifecycle. This remote opportunity combines scientific innovation, hands-on technical expertise, and cross-functional leadership in a highly regulated biotechnology environment. Your work will help advance promising radiopharmaceutical therapies and support the development of new treatment options for patients living with cancer. Accountabilities: - Lead biostatistical activities for clinical oncology development programs, developing and implementing statistical strategies, study designs, and analytical approaches aligned with clinical and regulatory objectives. - Provide statistical leadership across all phases of clinical development, including early-phase dose finding, dose optimization, pivotal trials, and registration-oriented studies. - Support interactions with global health authorities, including the FDA and EMA, by preparing statistical briefing materials, responding to agency questions, and contributing to regulatory submission packages.
- Author and maintain key statistical documentation, including statistical sections of clinical trial protocols, Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLF) shells. - Collaborate with multidisciplinary clinical development teams to ensure statistical deliverables, analytical objectives, and study milestones remain aligned and on schedule. - Identify, investigate, and resolve statistical and data analysis challenges affecting clinical trials, regulatory submissions, and development decisions. - Review and validate study documentation, statistical programming outputs, vendor deliverables, and analysis results to ensure accuracy, consistency, quality, and regulatory compliance. - Work closely with statistical programmers to support regulatory requests, Development Safety Update Reports (DSURs), Investigator's Brochures (IBs), scientific publications, and ad hoc analyses. - Participate in the ongoing review of clinical trial data, evaluating data integrity and identifying emerging efficacy, safety, and other clinically relevant trends. - Apply advanced statistical methods, including Bayesian approaches and simulation techniques, to support robust trial design and evidence generation. - Oversee external vendors and biometrics service providers, ensuring deliverables meet agreed timelines, quality expectations, and applicable regulatory standards. - Explore, pilot, and support the implementation of AI-enabled tools and workflows to improve statistical quality control, streamline operations, and increase productivity. - Maintain compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, applicable regulatory requirements, and internal standard operating procedures. - Communicate statistical findings and recommendations clearly to technical and nontechnical stakeholders, influencing decisions through rigorous analysis and evidence-based insights.
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