Executive Director, Biostatistics

Introduction: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 . We have an excellent opportunity for an Executive Director Biostatistics to join our is a hybrid position with2days a week onsite from our San Diego or Pasadena CAofficeSummary: 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 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 objectivesManages external vendor relationships including oversight of CRO selection RFP development contract negotiation and ongoing direction of outsourced statistics programming and data management activitiesOversees the authorship and review of Statistical Analysis Plans (SAPs) analysis data specifications and TLF (tables listings figures) standards across all programsDirects the statistical design of clinical trials including authorship of statistical sections of protocols sample size justifications and randomization strategiesPerforms hands-on statistical analyses using SAS R and related tools in support of study reporting exploratory analyses publications and presentations to internal and external stakeholdersReviews draft eCRFs programmed edit checks and data transfer specifications to ensure completeness and fitness for planned statistical analysesLeads statistical review of clinical data including specification and oversight of data surveillance listings programmatic data checks. Participates in development of data review systems and the Biostatistics function on project teams serving as a scientific resource and biometrics leader across development programsEstablishes and maintains documentation and archival standards for all Statistics deliverables ensuring study documentation is maintained in an audit-ready stateLeads the development maintenance and governance of Biostatistics standards including SOPs TLF standards CDISC implementation guidelines and Statistics work process documentationEnsures that all Statistics deliverables are produced in conformance with GCP ICH guidelines internal SOPs and applicable regulatory requirements supporting submission-readiness across programsAdheres to all department and company-wide policies regarding conduct performance and proceduresProvides oversight and direction to direct and indirect reports as applicable in accordance with the organizations 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 other duties as 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 also requires:Advanced knowledge of clinical trial design analysis methodology and drug development processesWorking knowledge of FDA/ICH guidelines CDISC standards and their application across clinical development programsSound scientific judgment with the ability to make well-reasoned decisions in a dynamic fast-paced environmentExcellent collaboration communication and decision-making skills with the ability to drive cross-functional alignment and influence without direct authorityAbility to prioritize objectives and manage competing demands across multiple programs in a dynamic working environmentCommitment to the values of integrity accountability transparency scientific rigor and driveAbility to effectively manage others through coaching and supervision in accordance with company policies and practices. Ensures employee performance meets the organizations expectations for conduct productivity quality continuous improvement and goal accomplishmentFamiliarity 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 travel may be required including travel between Xencors Pasadena and San Diego offices. Work for this position is generally performed at Xencors worksite and requires full-time commitment. Expected Base Salary Range: $278900 - $330000The actual salary will be based on the selected candidates qualifications including skills competencies education and offers a competitive total rewards package including 401k match healthcare coverage ESPP and a broad range of other addition this position will be eligible for an annual bonus and equity grant. For more information please see with Disabilities Act (ADA) StatementThe Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process please contact perform this job successfully an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential Employment Opportunity (EEO) StatementThe Company is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to age race color religion sex sexual orientation gender or gender identity national origin disability status protected veteran status or any other characteristic protected by state or federal does not accept profiles or resumes from recruiting vendors without a binding written agreement. Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor implied or otherwise.