Principal Biostatistician/Manager, Biostatistics
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 Principal Biostatistician/Manager, Biostatistics 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 Principal/Manager of Biostatistics to be accountable for study design, statistical analysis and reporting for programs in oncology, autoimmune disorders, asthma and allergic diseases. She/He will report to the Associate Director of Biostatistics.
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
- 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
- Proficiency with statistical programming in SAS and /or R
- MS. or Ph.D. degree in statistics, mathematics, or a related data science discipline. Pharmaceutical or relevant clinical CRO experience, including 2+ 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.
Americans with Disabilities Act (ADA) Statement
The Company will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, please contact HR@xencor.com.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Equal Employment Opportunity (EEO) Statement
The Company is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender or gender identity, national origin, disability status, protected veteran status or any other characteristic protected by state or federal law.
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