Xencor is an innovative, clinical-stage biotechnology 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 Principal Statistical Programmer to join our team. Our capabilities and the modular nature of our 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 technologies. Five XmAb® bispecific antibody programs are in clinical testing, and two more are expected to start clinical testing in the first half of 2019. 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 12 XmAb® drug candidates through clinical development, and the first antibody that incorporates an XmAb® technology has been approved for commercial marketing in the United States.
This individual will be a dynamic, technically strong and highly organized statistical programmer who can help Xencor standardize processes, expand program libraries and manage external vendor deliverables. The individual will have the opportunity to work with a highly talented and tight-knit multi-disciplinary team which helps you not only hone skills in programming but also develop skill sets outside of programming.
The individual will report to the Head of Statistical Programming.
• Act as the Lead Programmer for assigned projects. Attend multi-disciplinary team meetings, representing the programming function.
• Create or review and approve programming plans at study and project levels.
• Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, Analytics, SAPs, etc.).
• Communicate well with other stake-holders in translating concepts and requirements into technical specifications and providing multi-disciplinary teams with sensible programming solutions.
• 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.
• Provide hands on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR, DSUR, IB, Publications, etc.
• Work effectively with external vendors 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.
• Develop software systems to generate and/or validate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
• Write, modify, and maintain programs that produce diagnostics and listings for data review in support of Data Management. Carry out electronic data transfer (both incoming and outgoing), including support for sample reconciliation. Develop and review programs to ensure the data transfer has been produced to specification.
• 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.
• Create and document archives of software, outputs, and analysis files.
• Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
• Support the Head of Statistical Programming to achieve the corporate and department objectives.
• Provide time and resource estimates for project planning.
• BS Degree (MS preferred) in Biostatistics, Statistics, or a related quantitative discipline.
• Minimum of 7 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.
• Knowledge of CDASH and CDISC standards including but not limited to SDTM and ADaM models and experience in transforming raw data into those standards.
• Knowledge of relational databases, Good Clinical Practices, and 21CFR Part 11 Standards.
• Experience with Integrated Summary Safety/Efficacy Analyses, NDA/ BLA submissions.
Familiarity with Safety data and Coding Dictionaries (MedDRA and WHODD)
• Creating all documents necessary to support an electronic submission in the eCTD format.
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume to email@example.com. For further information about Xencor, please visit our website at www.xencor.com.