Summary:

The Executive Director, Biostatistics is responsible for leading and managing all biostatistics activities across Phase I through Phase III clinical programs in Oncology and Autoimmune diseases, with accountability for scientific rigor, regulatory compliance, and the development of a high-performing biostatistics team.

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. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities.
• Performs other duties as assigned.

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.

Position also 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
• Ability to prioritize objectives and manage competing demands across multiple programs in a dynamic working environment
• Commitment to the values of integrity, accountability, transparency, scientific rigor and drive
• Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization's expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment
• 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.

Occasional travel may be required, including travel between Xencor's Pasadena and San Diego offices. Work for this position is generally performed at Xencor's worksite and requires full-time commitment.

Expected Base Salary Range: $278,900 - $330,000

The actual salary will be based on the selected candidate's qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.