Sr. Manager / Associate Director, Translational Statistics
Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a fast-expanding clinical pipeline of promising therapeutic candidates, which creates an exciting opportunity for a Sr. Manager or Associate Director of Translational Statistics 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 eleven 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 Sr. Manager or Associate Director of Translational Statistics to be accountable for biomarker-related aspects of study designs, statistical analysis and reporting for biomarker endpoints, companion diagnostics development and collaborative analysis projects involving clinical development, Xencor research staff and external researchers. He/she will report to the Vice President of Biometrics.
Core Responsibilities include:
• Provides timely and scientifically sound statistical expertise to research and clinical development teams evaluating biomarkers and companion diagnostics
• Contributes to the development of biomarker, pharmacodynamic and other specialty-lab sections of clinical protocols, including selection of assays and analysis endpoints and authorship of statistical sections of protocols
• Develops analysis plans for biomarker endpoints and manages the execution of analyses and validation of results
• Collaborates with clinical statisticians to transition biomarker analysis outputs into specifications for study tables, listings and figures (TLFs) for clinical study reports as needed
• Performs statistical analyses using packages such as SAS, JMP and R in support of presentations, publications, advanced and exploratory analyses and prototyping of standard outputs
• Reviews data collection and sample management procedures for biomarker endpoints and coauthors data transfer specifications to ensure that all data necessary to meet the objectives of the study are collected appropriately
• Participates in sample management and reconciliation efforts, including tracking of samples from collection to reporting of assay results, and forensics related to sample-handling issues
• Represents Translation Statistics as an ad-hoc member of clinical study teams
• Curates all clinical biomarker and PD endpoint data and coordinates all external collaborations that require sharing these data
• Collaborates with clinical teams and PK/PD consultants in support of exposure-response analyses and PK/PD modeling
• Strong knowledge of biomarker and companion diagnostic development processes
• Experience with statistical software packages, such as SAS, JMP and R
• Excellent interpersonal, collaboration, communication and decision-making skills
• Knowledge of FDA/ICH guidelines and industry standard practices
• Working knowledge of submission requirements, e.g., Biologics License Applications (BLA) and Premarket Approvals (PMA)
• Independent, innovative, and a creative thinker
• 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 5+ years in biomarker statistics. Previous experience with oncology and early clinical development is preferred.
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