Executive Director, Biostatistics

Job Duties

• Provides strategic direction and oversight for the planning, execution, and reporting of statistical analyses across development programs, ensuring alignment with project team and executive committee objectives
• Manages external vendor relationships, including oversight of CRO selection, RFP development, contract negotiation, and ongoing direction of outsourced statistics, programming, and data management activities
• Oversees the authorship and review of Statistical Analysis Plans (SAPs), analysis data specifications, and TLF (tables, listings, figures) standards across all programs
• Directs the statistical design of clinical trials, including authorship of statistical sections of protocols, sample size justifications, and randomization strategies
• Performs hands-on statistical analyses using SAS, R, and related tools in support of study reporting, exploratory analyses, publications, and presentations to internal and external stakeholders
• Reviews draft eCRFs, programmed edit checks, and data transfer specifications to ensure completeness and fitness for planned statistical analyses
• Leads statistical review of clinical data, including specification and oversight of data surveillance listings, programmatic data checks. Participates in development of data review systems and processes
• Represents the Biostatistics function on project teams, serving as a scientific resource and biometrics leader across development programs
• Establishes and maintains documentation and archival standards for all Statistics deliverables, ensuring study documentation is maintained in an audit-ready state
• Leads the development, maintenance, and governance of Biostatistics standards, including SOPs, TLF standards, CDISC implementation guidelines, and Statistics work process documentation
• Ensures that all Statistics deliverables are produced in conformance with GCP, ICH guidelines, internal SOPs, and applicable regulatory requirements, supporting submission-readiness across programs
• Adheres to all department and company-wide policies regarding conduct, performance and procedures
• Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures

Education/Experience/Skills

• Position requires an M.S. degree in biostatistics, statistics, mathematics, or a closely related quantitative discipline; Ph.D. preferred
• A minimum of 16 years of Pharmaceutical, Biotechnology, or clinical CRO experience is required, including substantial experience in clinical statistics across multiple phases of development
• Requires proficiency with statistical packages including SAS and R, and a strong understanding of statistical methodology and programming principles
• A minimum of 7 years of people management experience is required, including experience leading and developing professional teams
• Oncology and/or autoimmune disease experience preferred
• Requires advanced knowledge of clinical trial design, analysis methodology, and drug development processes
• Working knowledge of FDA/ICH guidelines, CDISC standards, and their application across clinical development programs
• Sound scientific judgment with the ability to make well-reasoned decisions in a dynamic, fast-paced environment
• Excellent collaboration, communication, and decision-making skills, with the ability to drive cross-functional alignment and influence without direct authority
• Commitment to the values of integrity, accountability, transparency, scientific rigor and drive
• Ability to prioritize objectives and manage competing demands across multiple programs in a dynamic working environment
• Familiarity with AI tools and the ability to use them in a compliant and responsible manner, including validating outputs, mitigating risks, actively reinforcing responsible use across teams, and ensuring strict adherence to company policies and regulatory requirements