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 cytokines with improved function, with the goal of improving patient outcomes and quality of life. We have an excellent opportunity for a Contract-Sr. Biostatistician to join our team.
Our protein engineering capabilities and the modular nature of our XmAb technology allow us to quickly identify and create new platforms and drug candidates for potential development. We are advancing a deep clinical pipeline of novel drug candidates, including eight bispecific antibodies and two engineered cytokines, and more programs are expected to start clinical testing in 2022. We also leverage our many XmAb technologies by collaborating with leading global biopharmaceutical companies, including Genentech and Janssen Biotech, among others, and including our partnerships, 20 XmAb drug candidates are advancing through clinical development. Three XmAb medicines, to treat patients with a range of serious illnesses, such as aggressive lymphoma, rare blood disorders and COVID-19, are now marketed worldwide by partners.
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.
Responsible for the execution and reporting of statistical analyses with clinical data to the highest quality standards.
Job Duties Include:
- Support development of Statistical Analysis Plans (SAPs) and the execution of analyses and validation of results
- Assist in 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
- 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
- Adheres to all department and company-wide policies regarding conduct, performance and procedures
- Performs other duties as required.
Position requires a Master’s degree in statistics, mathematics, or a closely related statistical discipline; and at least 2 year clinical statistics in pharmaceutical or relevant clinical CRO experience. Previous experience with statistical packages including SAS also required.
The company reserves the right to consider internal experience in lieu of the education or experience requirements listed above.
Position also requires:
- Knowledge of drug development processes
- Sound understanding of statistics and programming concepts.
- Knowledge of FDA/ICH guidelines and industry standard practices
- Independent, innovative, and creative thinking
- Collaboration and communication skills
- Ability to multi-task as needed in a dynamic environment
- Commitment to the values of integrity, accountability, transparency, scientific rigor and drive.
Physical, Mental and Environment Demands:
The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Specific mental demands for the position are listed above under requirements. In addition, mental demands for this position include:
- Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
- Ability to work and sustain attention with distractions and/or interruptions.
- Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
- Ability to maintain regular attendance and be punctual.
- Ability to understand, remember and follow verbal and written instructions.
Occasional travel may be required, including travel between Xencor’s Monrovia and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.
Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Being fully vaccinated means that at least two weeks have passed since an individual’s final dose of an authorized COVID-19 vaccine regimen, including any boosters recommended by the CDC. New employees will be required to provide proof of their fully COVID-19 vaccinated status as of their start date unless an exemption or accommodation is approved.
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.
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.