Xencor is an innovative, clinical-stage biopharmaceutical company located in the Los Angeles area (near Pasadena) and in San Diego. We use our pioneering XmAb® technology to discover and develop better biotherapeutics – antibodies and other proteins with improved function – with the goal of improving patient outcomes and quality of life, and we have an excellent opportunity for a Statistical Programmer to join our team.
Our capabilities and the modular nature of XmAb technology allows us to quickly identify and create new platforms and drug candidates for potential development. We are developing a deep pipeline of novel drug candidates enabled by the rapid expansion of our bispecific antibody and cytokine technologies. Nine XmAb bispecific antibody programs are in clinical testing, and more are expected to start clinical testing in 2021. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. We and our partners are advancing 18 XmAb drug candidates through clinical development, and two medicines that incorporate XmAb technology are approved for commercial marketing.
We seek a Statistical Programmer to support the statistical programming department. This individual need to be technically strong and highly organized who can help Xencor standardize processes, expand program libraries, and help manage external vendor deliverables.
• Provide hands on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR, DSUR, IB, Publications, etc. • Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, Analytics, SAPs, etc.).
• Provide 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 requirements.
• Work effectively to ensure timely delivery of quality products and provide feedback via Acceptance testing of datasets, TLFs etc.
• Create or review and approve CDISC-compliant deliverable including annotated CRFs, datasets and corresponding documentation for electronic submission to regulatory agencies.
• Write, modify, and maintain programs that produce diagnostics and listings for data review in support of other functions as per directions from Statistical Programming Leads.
• Assist in developing standards related to statistical programming.
• Assist the team in planning and developing data monitoring tools such as visual analytics, patient profiles, programming checks etc.
• Assist team leads in reviewing draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• BS Degree (MS preferred) in Biostatistics, Statistics, or a related quantitative discipline.
• Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Oncology and Auto-immune experience preferred.
• Knowledge of 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.
• Experience leading projects and teams will be a plus.
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