Sr. Manager, Biostatistics

Sr. Manager, Biostatistics

Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit www.xencor.com. We have an excellent opportunity for an Sr. Manager, Biostatistics, to join our team.

This position is a hybrid role with 2 days a week onsite in our San Diego, Ca. office

Summary:

Responsible for the planning, execution and reporting of statistical aspects of clinical trials.

Job Duties:

• 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 Biostatistics function on study teams and other sponsor teams
• Defines and implements documentation and archival standards for Biostatistics deliverables and ensures that study documentation is in an audit-ready state
• Ensures that Biotatistic’s 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
• Understands the strategic goals of the Biostatistics function and participates in shaping the vision of Biostatistics and Biometrics
• Proactively implements instructions from line management
• Assist line managers in cultivating and maintaining collaborative and process-oriented working environment
• Performs other duties as required

Education/Experience/Skills:

Position requires a Master’s degree in statistics, mathematics, or a closely related statistical discipline, Ph.D. preferred, plus a minimum of 8 years’ Pharmaceutical or relevant clinical CRO experience, including at least 5 years in clinical Biostatistics.  Also requires previous experience with statistical packages including SAS.

Position also requires:

• Ability to demonstrate leadership and influential skills regarding general biostatistics processes and related functions
• Strong 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
• Excellent collaboration, communication and decision-making skills
• Ability to multi-task as needed in a dynamic environment
• Commitment to the values of integrity, accountability, transparency, scientific rigor and drive
• Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model.

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 Pasadena and San Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Expected Base Salary Range:  $166,000 - $190,500

The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits.  In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.

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.