Sr. Manager, Statistical Programming

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 a Sr. Manager Statistical Programming to join our position will be based out of our San Diego CA. office and is hybrid with 2 days a week : Responsible for managing and supporting the statistical analysis and reporting of data from clinical studies by serving as lead programming and overseeing CRO full-service vendor performance and partnering with cross functional study Responsibilities:Attends multi-disciplinary team meetings representing the programming functionPartners with cross functional study teams to ensure delivery of results for the Xencor portfolioCreates or reviews and approves programming plans at study and project levelsProvides input on key study-related documents produced by other functions (e.g. CRFs Data Management Plan Analytics SAPs etc.)Communicates effectively with other stakeholders translating concepts and requirements into technical specifications and providing multi-disciplinary teams with sensible programming solutionsProvides input to specifications to ensure that statistical programming elements are in line with the overall deliverable and adhere to ICH guidelines Good Clinical Practices and regulatory requirementsProvides hands-on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR DSUR IB Publications effectively with external vendors to ensure timely delivery of quality products and provide feedback via Acceptance testing of datasets TLFs CRO full-service vendors and assist management with evaluating performanceAssists manager with evaluating resources for assigned programsCreates or reviews and approves CDISC-compliant deliverable including annotated CRFs datasets and corresponding documentation for electronic submission to regulatory agenciesDevelops software systems to generate and/or validate displays of clinical study data as tables listings and graphs for electronic submission to regulatory agenciesWrites modifies and maintains programs that produce diagnostics and listings for data review in support of Data ManagementCarries out electronic data transfer (both incoming and outgoing) including support for sample reconciliation. Develops and reviews programs to ensure the data transfer has been produced to specification. Assists in developing standards related to statistical programming. Assists the team in planning and developing data monitoring tools such as visual analytics patient profiles programming checks etc. Creates and documents archives of software outputs and analysis files. Reviews draft clinical reports journal articles slide presentations and other documents to assure that results are reported accuratelySupports Statistical Programming leadership to achieve the corporate and department objectivesProvides time and resource estimates for project planningAdheres 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 a Bachelors degree in Biostatistics Statistics or a related quantitative discipline Masters degree preferred and at least 6 years of statistical programming experience in the Pharmaceutical Biotechnology or Contract Research Industry. Requires prior experience using SAS/Base SAS/Macro SAS/STAT SAS/Graph and SAS/SQL in a windows environment to develop and validate analysis datasets tables listings and figures/graphs is preferred as is experience leading projects and teams. Also requires experience with Integrated Summary Safety/Efficacy Analyses NDA/ BLA submissions. Hematology Oncology experience is preferredPosition also requires:Knowledge of CDASH and CDISC standards including but not limited to SDTM and ADaM models Knowledge of relational databases Good Clinical Practices and 21CFR Part 11 Standards. Familiarity with Safety data and Coding Dictionaries (MedDRA and WHODD) Ability to create all documents necessary to support an electronic submission in the eCTD formatAbility to act independently and carry out responsibilities in an innovative and creative mannerAbility to multi-task as needed in a dynamic environmentCommitted to the values of integrity accountability transparency scientific rigor and to demonstrate competencies applicable for job based on Xencors Leadership Competency ModelAbility 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 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: $175000 - $200400The 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.