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Xencor

Senior Manager Biostatistics

Biostats – San Diego, California
Department Biostats
Employment Type Full Time
Minimum Experience Experienced

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/an [insert title] to join our team.

Our capabilities and the modular nature of our technology allow 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, and seven XmAb bispecific antibody programs are in clinical testing. We also leverage our many XmAb technologies by engaging in multiple collaborations with leading global biopharmaceutical companies, including Novartis, Amgen and Genentech, among others. Including our partners, over a dozen XmAb drug candidates are advancing through clinical development, and the first antibody that incorporates an XmAb technology has been approved for commercial marketing in the United States.

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 Senior Manager of Biostatistics to be accountable for study design, statistical analysis and reporting for programs in oncology, autoimmune disorders, asthma and allergic diseases. He/She will report to the 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

 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

Qualifications: 

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 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 recruiting@xencor.com.  For further information about Xencor, please visit our website at www.xencor.com  

Xencor does not accept profiles or resumes from recruiting vendors without a binding written agreement.

Any unsolicited submission of services and or resumes in no way creates an obligation or duty by Xencor, implied or otherwise.

 

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  • Location
    San Diego, California
  • Department
    Biostats
  • Employment Type
    Full Time
  • Minimum Experience
    Experienced
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