Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have an expanding clinical pipeline of promising therapeutic candidates and an immediate requirement for a Manager of Biostatistics 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 twelve 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, Astellas and Genentech.
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 Manager of Biostatistics to be accountable for study design, statistical analysis and reporting for programs in oncology, autoimmune disorders, asthma and allergic diseases.
Core Responsibilities include:
• Responsible for the direction, planning, execution and reporting of statistical analyses with clinical data to the highest quality standards
• Develops Statistical Analysis Plans (SAPs) and manages the execution of analyses and validation of results
• Responsible for the statistical design of clinical trials, including authorship of statistical sections of protocols
• Responsible for preparation of specifications for study tables, listings and figures (TLFs)
• Performs statistical analyses using packages such as SAS and R in support of presentations, publications, advanced and exploratory analyses, prototyping of standard outputs and general study reporting
• Reviews draft eCRFs, programmed edit checks and data transfer specifications to ensure that all data necessary to meet the objectives of the study are collected appropriately
• Participates in the review of clinical data, including specification of custom review listings and programmatic data checks and outputs from the data review checks
• Represents the Statistics function on study teams
• Defines and implements documentation and archival standards for Statistics deliverables and ensures that study documentation is in an audit-ready state
• Ensures that statistics deliverables are produced in accordance with GCP, internal SOPs and all regulatory requirements
• Strong knowledge of drug development processes
• Knowledge of FDA/ICH guidelines and industry standard practices
• Independent, innovative, and creative thinker
• Excellent collaboration, communication and decision-making skills
• Ability to multi-task as needed in a dynamic environment
• Committed to the values of integrity, accountability, transparency, scientific rigor and drive
Ph.D. or M.S. degree in statistics, mathematics, or a closely-related statistical discipline. Pharmaceutical or relevant clinical CRO experience, including 3+ years in clinical statistics. Previous experience with statistical packages including SAS and a sound understanding of statistics and programming concepts.
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
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