Xencor
Manager, Statistical Programming
Xencor, San Diego, California, United States, 92189
Manager, Statistical Programming
Introduction:
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 a
Manager, Statistical Programming,
to join our team.
This position will be based out of our San Diego office and hybrid 2 days a week on-site.
Summary:
Responsible for supporting the statistical analysis and reporting of data from clinical studies while serving as Lead Programmer for assigned projects.
Job Duties and Responsibilities:Oversees CRO full-service vendor performancePartners with cross functional study teams to ensure delivery of results for the Xencor portfolioAttends multi-disciplinary team meetings, representing the programming functionCreates or reviews and approves programming plans at study and project levelsProvides input on key study-related documents produced by other functions (e.g., CRFs, Data Management Plan, Analytics, SAPs, etc.)Communicates effectively with other stakeholders, translating concepts and requirements into technical specifications and providing multi-disciplinary teams with sensible programming solutionsProvides input to specifications to ensure that statistical programming elements are in line with the overall deliverable and adhere to ICH guidelines, Good Clinical Practices, and regulatory requirementsProvides hands-on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR, DSUR, IB, Publications, etc.Works effectively with external vendors to ensure timely delivery of quality products and provide feedback via Acceptance testing of datasets, TLFs etc.Creates or reviews and approves CDISC-compliant deliverable including annotated CRFs, datasets and corresponding documentation for electronic submission to regulatory agenciesDevelops software systems to generate and/or validate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agenciesWrites, modifies, and maintains programs that produce diagnostics and listings for data review in support of Data ManagementCarries out electronic data transfer (both incoming and outgoing), including support for sample reconciliationDevelops and reviews programs to ensure the data transfer has been produced to specification.Assists in developing standards related to statistical programmingAssists the team in planning and developing data monitoring tools such as visual analytics, patient profiles, programming checks etc.Creates and documents archives of software, outputs, and analysis filesReviews draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accuratelySupports Statistical Programming leadership to achieve the corporate and department objectivesProvides time and resource estimates for project planningAdheres to all department and company-wide policies regarding conduct, performance and proceduresPerforms other duties as required.Education/Experience/Skills:
Position requires a Bachelor's degree in Biostatistics, Statistics, or a related quantitative discipline; Master's degree preferred, and at least 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Requires prior experience using SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment to develop and validate analysis datasets, tables, listings, and figures/graphs is preferred, as is experience leading projects and teams. Also requires experience with Integrated Summary Safety/Efficacy Analyses, NDA/ BLA submissions. Hematology Oncology experience is preferred
Position also requires
:
Knowledge of CDASH and CDISC standards including but not limited to SDTM and ADaM models and experience in transforming raw data into those standards.Knowledge of relational databases, Good Clinical Practices and 21CFR Part 11 Standards.Familiarity with Safety data and Coding Dictionaries (MedDRA and WHODD)Ability to create all documents necessary to support an electronic submission in the eCTD formatAbility to act independently and carry out responsibilities in an innovative and creative mannerAbility to multi-task as needed in a dynamic environmentCommitted to the values of integrity, accountability, transparency, scientific rigor and driveAbility to demonstrate competencies applicable for job based on Xencor's Leadership Competency Model.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.
Expected Base Salary Range: $137,250 to $162,350
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.
Other details
Job Family Manager JobsPay Type SalaryEmployment Indicator Hybrid
Apply Now
Introduction:
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 a
Manager, Statistical Programming,
to join our team.
This position will be based out of our San Diego office and hybrid 2 days a week on-site.
Summary:
Responsible for supporting the statistical analysis and reporting of data from clinical studies while serving as Lead Programmer for assigned projects.
Job Duties and Responsibilities:Oversees CRO full-service vendor performancePartners with cross functional study teams to ensure delivery of results for the Xencor portfolioAttends multi-disciplinary team meetings, representing the programming functionCreates or reviews and approves programming plans at study and project levelsProvides input on key study-related documents produced by other functions (e.g., CRFs, Data Management Plan, Analytics, SAPs, etc.)Communicates effectively with other stakeholders, translating concepts and requirements into technical specifications and providing multi-disciplinary teams with sensible programming solutionsProvides input to specifications to ensure that statistical programming elements are in line with the overall deliverable and adhere to ICH guidelines, Good Clinical Practices, and regulatory requirementsProvides hands-on programming and validation support for statistical programming tasks that are required for various deliverables such as CSR, DSUR, IB, Publications, etc.Works effectively with external vendors to ensure timely delivery of quality products and provide feedback via Acceptance testing of datasets, TLFs etc.Creates or reviews and approves CDISC-compliant deliverable including annotated CRFs, datasets and corresponding documentation for electronic submission to regulatory agenciesDevelops software systems to generate and/or validate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agenciesWrites, modifies, and maintains programs that produce diagnostics and listings for data review in support of Data ManagementCarries out electronic data transfer (both incoming and outgoing), including support for sample reconciliationDevelops and reviews programs to ensure the data transfer has been produced to specification.Assists in developing standards related to statistical programmingAssists the team in planning and developing data monitoring tools such as visual analytics, patient profiles, programming checks etc.Creates and documents archives of software, outputs, and analysis filesReviews draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accuratelySupports Statistical Programming leadership to achieve the corporate and department objectivesProvides time and resource estimates for project planningAdheres to all department and company-wide policies regarding conduct, performance and proceduresPerforms other duties as required.Education/Experience/Skills:
Position requires a Bachelor's degree in Biostatistics, Statistics, or a related quantitative discipline; Master's degree preferred, and at least 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Requires prior experience using SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment to develop and validate analysis datasets, tables, listings, and figures/graphs is preferred, as is experience leading projects and teams. Also requires experience with Integrated Summary Safety/Efficacy Analyses, NDA/ BLA submissions. Hematology Oncology experience is preferred
Position also requires
:
Knowledge of CDASH and CDISC standards including but not limited to SDTM and ADaM models and experience in transforming raw data into those standards.Knowledge of relational databases, Good Clinical Practices and 21CFR Part 11 Standards.Familiarity with Safety data and Coding Dictionaries (MedDRA and WHODD)Ability to create all documents necessary to support an electronic submission in the eCTD formatAbility to act independently and carry out responsibilities in an innovative and creative mannerAbility to multi-task as needed in a dynamic environmentCommitted to the values of integrity, accountability, transparency, scientific rigor and driveAbility to demonstrate competencies applicable for job based on Xencor's Leadership Competency Model.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.
Expected Base Salary Range: $137,250 to $162,350
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.
Other details
Job Family Manager JobsPay Type SalaryEmployment Indicator Hybrid
Apply Now