CON-Statistical Programmer

This is a 6- to 8-month contract position supporting the Statistical Programming team., The Contract Statistical Programmer supports statistical analysis and reporting for clinical studies and related regulatory deliverables as an individual contributor on assigned projects., * 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.

Do you have experience in Windows?, Do you have a Bachelor’s degree?, 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., * 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.

12770 El Camino Real, San Diego, CA 92130 Hybrid work $75 - $100 an hour - Full-time

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.