Director, Early Phase Biostatistics

Job Summary

This Director, Biostatistics position provides statistical leadership and hands-on delivery for Early Phase Biostatistics supporting EDO (Early Development Oncology). The position is accountable for the statistical strategy, scientific quality, and timely delivery of Biostatistics support across multiple assigned studies and/or projects through POC (proof of concept) and transition to late-stage development. The incumbent serves as the Biostatistics representative on Global Project Teams (GPTs) and study teams and directly leads or delivers key statistical activities, including study design, protocol and clinical study report development, statistical analysis plans, analysis specifications, modeling and simulation, review of mock tables, figures, and listings (TFLs), and quality review of ADaM datasets and TFLs. The incumbent partners with EDO stakeholders on clinical development strategy, endpoint design and selection, dose escalation, dose and schedule optimization, cohort expansion, proof-of-concept assessment, and program advancement decisions. The position provides statistical leadership and oversight across assigned studies and/or projects, supports global regulatory strategy and Health Authority interactions, and manages competing priorities in a fast-paced, dynamic environment. The incumbent applies advanced knowledge of clinical trial design and analysis, including dose-finding methodologies, adaptive and innovative trial designs, biomarker-driven development, modeling and simulation, and emerging statistical approaches relevant to early oncology drug development. The incumbent may coach statisticians and contribute to Early Phase and Global Biostatistics standards, capabilities, and strategic initiatives. The position works closely with Data Management and Statistical Programming to ensure timely, high-quality study deliverables.

Responsibilities

Hands-on Statistical Leadership and Delivery

• Provides hands-on statistical leadership and delivery across multiple assigned Early Phase studies and/or projects and serves as the Biostatistics representative on GPTs and study teams.

• Leads or directly contributes to protocol development, case report form review, statistical analysis plans and analysis specifications, statistical programming specifications, modeling and simulation, statistical analyses, results interpretation, clinical study reports, regulatory documents, and scientific communications.

• Develops and/or reviews mock TFLs and performs quality review of ADaM datasets, TFLs, and other statistical deliverables to ensure accuracy, consistency with the protocol and SAP, and fitness for the intended decision-making purpose.

• Works closely with Data Management, Statistical Programming, CROs, and other partners to resolve implementation issues and ensure high-quality, timely delivery.

• Plans and manages the scope, timelines, priorities, dependencies, and resources for assigned statistical deliverables and proactively communicates and escalates material risks or gaps.

• Maintains accountability for delegated CRO/vendor statistical activities, including scientific quality, compliance, budget and timeline expectations.

Early Development Strategy and Decision Support

• Provides statistical strategy and consultation for assigned EDO studies and projects, including innovative study design, endpoint selection, dose escalation, dose and schedule optimization, cohort expansion, biomarkers, proof-of-concept assessment, and program advancement or transition decisions.

• Partners with study and project teams to evaluate statistical assumptions, decision criteria, uncertainties, risks, and trade-offs, and communicates clear, technically sound recommendations to relevant stakeholders.

• Ensures statistical strategies are scientifically rigorous, operationally feasible, and aligned with regulatory expectations and the intended decision framework.

• Provides statistical input to global regulatory strategies, briefing packages, submissions, responses, and Health Authority interactions.

Statistical Methodology, Collaboration, and Capability Development

• Applies and promotes fit-for-purpose statistical methods, including Bayesian and adaptive designs, dose-finding approaches, modeling and simulation, biomarker analyses, and quantitative decision-making frameworks relevant to early oncology development.

• Provides technical consultation on complex statistical and implementation questions and supports consistent application of statistical standards and best practices.

• Leads or contributes to functional and cross-functional initiatives that strengthen statistical excellence, knowledge sharing, innovation, and operational effectiveness within Early Phase and Global Biostatistics.

• Coaches and mentors statisticians and promotes effective engagement, clear communication, and collaboration across functions, regions, and external partners.

Qualifications

Education Qualifications

• PhD in statistics or biostatistics required

Experience Qualifications

• 7+ Years of relevant experience in the pharmaceutical industry and/or academic clinical research

• 3+ Years of experience n Early Phase clinical development experience, either in academic clinical research or biopharmaceutical industry

Competencies

• Demonstrated experience providing statistical leadership for complex Early Phase oncology programs and studies, including dose-finding, dose optimization, and proof-of-concept assessments

• Strong knowledge of statistical methodologies relevant to Early Phase development, such as Bayesian methods, adaptive designs, dose-finding approaches, modeling and simulation, and statistical decision-making frameworks.

• Experience working on global project or cross-functional teams across regions and time zones.

• Experience supporting regulatory strategy, briefing documents, responses to regulatory questions, and Health Authority interactions, including IND and end-of-Phase 2 milestones.

• Strong written and verbal communication skills, including the ability to communicate statistical recommendations, uncertainties, risks, and trade-offs to non-statistical stakeholders

• Proficiency in SAS and/or R required.

• Strong understanding and practical experience in statistical analyses and interpretation of biomarker, PK/PD, immunogenicity, safety, and efficacy endpoints commonly used in Early Phase oncology development.

• Demonstrated ability to provide timely statistical consultation and recommendations in fast-paced, cross-functional discussions.

• Demonstrated ability to evaluate multiple statistical design options and guide selection of fit-for-purpose development strategies

• Hands-on experience developing SAPs and analysis specifications; supporting protocol and CSR development; conducting or reviewing modeling and simulation; reviewing mock TFLs; and performing quality review of ADaM datasets and TFLs.

• Ability to represent Biostatistics effectively on GPTs and cross-functional study teams and to balance hands-on delivery with study- and project-level statistical strategy.

• Ability to independently lead and deliver statistical work across multiple concurrent studies and/or projects in a fast-paced, dynamic environment

Travel Requirements

• Ability to travel up to 20% of the time. International travel required