Principal Statistical Programmer
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. For more information, please visit www.xencor.com. We have an excellent opportunity for a Principal Statistical Programmer to join our team in San Diego, CA.
This position is a hybrid position with 2 days onsite weekly in our San Diego, CA. office.
Summary:
Responsible for supporting the statistical analysis and reporting of data from assigned clinical studies.
Job Duties:
Serve as the lead programmer for assigned projects; attends multi-disciplinary team meetings, representing the programming function; Oversee CRO Full-Service Vendor performance; Partner with cross-functional study teams to ensure delivery of the Xencor portfolio; Create or review and approve programming plans at study and project levels; Provide input on key study-related documents produced by other functions (e.g., CRFs, Data Management Plan, Analytics, SAPs, etc.); Communicate effectively with other stakeholders in translating concepts and requirements into technical specifications and providing multi-disciplinary teams with sensible programming solutions; Provide input to specifications to ensure that statistical programming elements are in line with the overall deliverable and adhere to ICH guidelines, Good Clinical Practice, and regulatory requirements; Provide hands on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR, DSUR, lB, Publications, etc; Work effectively with external vendors to ensure timely delivery of quality products and provide feedback via Acceptance testing of datasets, TLFs etc; Create or review and approve CDISC-compliant deliverable including annotated CRFs, datasets and corresponding documentation for electronic submission to regulatory agencies; Develop software systems to generate and/or validate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies; Write, modify, and maintain programs that produce diagnostics and listings for data review in support of Data Management. Carry out electronic data transfer (both incoming and outgoing), including support for sample reconciliation; Develop and review programs to ensure the data transfer has been produced to specification; Assists in developing standards related to statistical programming; Assist the team in planning and developing data monitoring tools such as visual analytics, patient profiles, programming checks etc; Create and document archives of software, outputs, and analysis files; Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately; Provide time and resource estimates for project planning; Adhere to all department and company-wide policies regarding conduct, performance and procedures; Perform other duties as required.
Education/Experience/Skills:
Position requires a Bachelor’s degree in Biostatistics, Statistics or an industry related field such as Pharmacy, and five years of statistical programming experience in pharmaceutical or biotechnology industry.
Position also requires:
Position also requires prior experience transforming raw data into CDASH and CHISC standards, including but not limited to SDTM and ADaM models. Experience leading projects and teams also required. Knowledge of using SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, or SAS/SQL in a windows environment to develop and validate analysis datasets, tables, listings, and figures/graphs; Knowledge of CDASH and CDISC standards including but not limited to SDTM and ADaM models; Knowledge of relational databases, Good Clinical Practices, and 21 CFR Part 11 Standards; Familiarity with Safety data and Coding Dictionaries (MedDRA and WHODD) and creating all documents necessary to support an electronic submission in the eCTD format.
Occasional travel may be required, including travel between Xencor’s and Pasadena and Diego offices. Work for this position is generally performed at Xencor’s worksite and requires full-time commitment.
Expected Base Salary Range: $120,000.00 - $160,000.00
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/.
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. New employees will be required to provide proof of their COVID-19 vaccination 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.
Apply at https://www.xencor.com/careers