CON-Statistical Programmer

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 position is based in San Diego California and follows a hybrid work arrangement with the potential to be fully : This is a 6- to 8-month contract position supporting the Statistical Programming Summary: The Contract Statistical Programmer supports statistical analysis and reporting for clinical studies and related regulatory deliverables as an individual contributor on assigned Responsibilities:Support statistical programming activities for assigned studies and deliverables under the direction of internal team in cross-functional meetings as needed to support programming to study- and project-level programming plans and input on key study documents developed by other functions including CRFs data management plans analytics outputs and effectively with stakeholders to translate business needs into technical specifications and practical programming ensure programming specifications align with deliverable requirements ICH guidelines Good Clinical Practice and applicable regulatory hands-on programming and validation support for clinical and regulatory deliverables including CSRs DSURs investigator brochures and CDISC-compliant deliverables including annotated CRFs datasets and submission documentation for regulatory and validate programs used to generate tables listings and figures for clinical study reporting and regulatory modify and maintain programs that generate diagnostics and listings to support data review and data management incoming and outgoing electronic data transfers including sample reconciliation and review programs to ensure data transfers are produced according to to the development and maintenance of statistical programming standards tools and with the development of data monitoring tools including visual analytics patient profiles and programming and maintain archives of programs outputs and analysis draft clinical reports manuscripts presentations and related materials to help ensure accurate reporting of departmental and company objectives through high-quality timely programming time and resource estimates to support project to department and company policies procedures and performance other duties as degree in Biostatistics Statistics or a related quantitative discipline required; Masters 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 Qualifications:Knowledge of CDASH and CDISC standards including SDTM and ADaM and experience transforming raw data to those of relational databases Good Clinical Practice and 21 CFR Part 11 with safety data and coding dictionaries including MedDRA and to create documentation required to support electronic submissions in eCTD to work independently and manage responsibilities with sound judgment and to manage multiple priorities in a fast-paced to integrity accountability transparency scientific rigor and competencies aligned with Xencors professional expectations for the Hourly Pay Range: $75.00 to $100.00 per hourActual compensation will depend on the selected candidates qualifications including skills experience and education. For additional information about Xencor please see with Disabilities Act (ADA) StatementThe 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 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 Employment Opportunity (EEO) StatementThe 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.