Executive Director, Biostatistics

Introduction:Xencor•San Diego, CA

6d•Hybrid

About The Position

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for an Executive Director, Biostatistics, to join our team. This is a hybrid position with 2 days a week onsite from our San Diego or Pasadena, CA office. 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.

Requirements

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.
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.
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.

Nice To Haves

Ph.D. preferred.
Oncology and/or autoimmune disease experience preferred.

Responsibilities

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.