Position: Principal Statistical Programmer
San Diego, CA
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have an excellent opportunity for a Principal Statistical Programmer to join our team. We use our pioneering XmAb® technology to develop better biotherapeutics – antibodies that target new biological mechanisms and are more potent, safer and longer lasting – to improve patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with eight in clinical testing by Xencor or our partners, our XmAb® technology has been validated through our collaborative agreements with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim.
Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
We seek a Principal Statistical Programmer to play a lead role in supporting the statistical analysis and reporting of data from clinical studies, to oversee CRO Full Service Vendor performance, and to partner with cross functional study teams to ensure delivery of the Xencor portfolio. This individual achieves results through effective communication, teamwork, performance management, collaboration with other groups and a commitment to serving internal and external customers and stakeholders.
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 firstname.lastname@example.org. For further information about Xencor, please visit our website at www.xencor.com.