Introduction:
Xencor is a public, clinical-stage biopharmaceutical company with locations in Pasadena and San Diego, California. We are advancing a pipeline of XmAb® bispecific T-cell engagers and other engineered drug candidates built on our differentiated technology platforms. Our goal is to develop 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 commercialized by partners. Xencor is seeking a Contract Statistical Programmer to join our team.
This position is based in San Diego, California, and follows a hybrid work arrangement, with the potential to be fully remote.
Summary:
This is a 6- to 8-month contract position supporting the Statistical Programming team.
Position Summary:
The Contract Statistical Programmer supports statistical analysis and reporting for clinical studies and related regulatory deliverables as an individual contributor on assigned projects.
Primary Responsibilities:
- Support statistical programming activities for assigned studies and deliverables under the direction of internal team leadership.
- Participate in cross-functional meetings as needed to support programming deliverables.
- Contribute to study- and project-level programming plans and documentation.
- Provide input on key study documents developed by other functions, including CRFs, data management plans, analytics outputs, and SAPs.
- Communicate effectively with stakeholders to translate business needs into technical specifications and practical programming solutions.
- Help ensure programming specifications align with deliverable requirements, ICH guidelines, Good Clinical Practice, and applicable regulatory standards.
- Provide hands-on programming and validation support for clinical and regulatory deliverables, including CSRs, DSURs, investigator brochures, and publications.
- Create CDISC-compliant deliverables, including annotated CRFs, datasets, and submission documentation for regulatory filings.
- Develop and validate programs used to generate tables, listings, and figures for clinical study reporting and regulatory submission.
- Write, modify, and maintain programs that generate diagnostics and listings to support data review and data management activities.
- Support incoming and outgoing electronic data transfers, including sample reconciliation activities.
- Develop and review programs to ensure data transfers are produced according to specification.
- Contribute to the development and maintenance of statistical programming standards, tools, and processes.
- Assist with the development of data monitoring tools, including visual analytics, patient profiles, and programming checks.
- Create and maintain archives of programs, outputs, and analysis files.
- Review draft clinical reports, manuscripts, presentations, and related materials to help ensure accurate reporting of results.
- Support departmental and company objectives through high-quality, timely programming deliverables.
- Provide time and resource estimates to support project planning.
- Adhere to department and company policies, procedures, and performance expectations.
- Perform other duties as assigned.
Education/Experience/Skills:
Bachelor’s degree in Biostatistics, Statistics, or a related quantitative discipline required; Master’s degree preferred. Candidates should have at least 6 years of statistical programming experience in the pharmaceutical, biotechnology, or contract research industry. Strong experience with SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a Windows environment is preferred, including development and validation of analysis datasets, tables, listings, and figures. Experience supporting clinical studies, regulatory submissions, and integrated summary safety and efficacy analyses is strongly preferred. Hematology/oncology experience is preferred.
Additional Qualifications:
- Knowledge of CDASH and CDISC standards, including SDTM and ADaM, and experience transforming raw data to those standards.
- Knowledge of relational databases, Good Clinical Practice, and 21 CFR Part 11 requirements.
- Familiarity with safety data and coding dictionaries, including MedDRA and WHODrug.
- Ability to create documentation required to support electronic submissions in eCTD format.
- Ability to work independently and manage responsibilities with sound judgment and initiative.
- Ability to manage multiple priorities in a fast-paced environment.
- Commitment to integrity, accountability, transparency, scientific rigor, and execution.
- Demonstrated competencies aligned with Xencor’s professional expectations for the role.
Expected Hourly Pay Range: $75.00 to $100.00 per hour
Actual compensation will depend on the selected candidate’s qualifications, including skills, experience, and education. For additional information about Xencor, 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
[email protected].
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.
