Sr. Manager, Statistical Programming
Xencor
2 days ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Summary:
Responsible for managing and supporting statistical analysis and reporting of data from clinical studies by serving as lead programming and overseeing CRO full-service vendor performance while partnering with cross-functional study teams.
Primary Responsibilities:
- Attend multi-disciplinary team meetings, representing the programming function
- Partner with cross-functional study teams to deliver results for the Xencor portfolio
- Create/review/approve programming plans at study and project levels
- Provide input to study documents (e.g., CRFs, Data Management Plan, Analytics, SAPs)
- Translate concepts/requirements into technical specifications and provide programming solutions
- Provide input to specifications to align statistical programming with ICH, GCP, and regulatory requirements
- Provide hands-on programming/validation support for deliverables (CSR, DSUR, IB, publications)
- Work with external vendors; provide feedback via acceptance testing of datasets, TLFs, etc.
- Oversee CRO full-service vendors and assist in evaluating performance
- Create/review/approve CDISC-compliant deliverables (annotated CRFs, datasets, submission documentation)
- Develop software to generate/validate tables, listings, and graphs for electronic regulatory submission
- Write/maintain programs to produce diagnostics and listings for Data Management review
- Perform electronic data transfers (incoming/outgoing), including sample reconciliation; ensure transfer meets specifications
- Assist in developing statistical programming standards and data monitoring tools (visual analytics, patient profiles, programming checks)
- Create/document archives of software, outputs, and analysis files
- Review draft clinical reports, journal articles, slide presentations, and other documents for accurate reporting
- Support Statistical Programming leadership and provide time/resource estimates for planning
- Adhere to department/company policies; provide oversight to direct/indirect reports
Qualifications (Education/Experience):
- Bachelor’s degree in Biostatistics, Statistics, or related quantitative discipline; Master’s preferred
- At least 6 years of statistical programming experience in pharma/biotech/CRO
- Prior experience with SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL (Windows) to develop/validate analysis datasets, tables, listings, figures/graphs
- Experience with Integrated Summary Safety/Efficacy Analyses and NDA/BLA submissions (Hematology Oncology preferred)
Skills/Position Requirements:
- Knowledge of CDASH and CDISC standards (SDTM, ADaM)
- Knowledge of relational databases, GCP, and 21 CFR Part 11
- Familiarity with safety data and coding dictionaries (MedDRA, WHODD)
- Ability to create eCTD submission documents
- Ability to work independently, multi-task, and act innovatively
Application Instructions:
For more information, please see https://xencor.com/careers/.
Responsible for managing and supporting statistical analysis and reporting of data from clinical studies by serving as lead programming and overseeing CRO full-service vendor performance while partnering with cross-functional study teams.
Primary Responsibilities:
- Attend multi-disciplinary team meetings, representing the programming function
- Partner with cross-functional study teams to deliver results for the Xencor portfolio
- Create/review/approve programming plans at study and project levels
- Provide input to study documents (e.g., CRFs, Data Management Plan, Analytics, SAPs)
- Translate concepts/requirements into technical specifications and provide programming solutions
- Provide input to specifications to align statistical programming with ICH, GCP, and regulatory requirements
- Provide hands-on programming/validation support for deliverables (CSR, DSUR, IB, publications)
- Work with external vendors; provide feedback via acceptance testing of datasets, TLFs, etc.
- Oversee CRO full-service vendors and assist in evaluating performance
- Create/review/approve CDISC-compliant deliverables (annotated CRFs, datasets, submission documentation)
- Develop software to generate/validate tables, listings, and graphs for electronic regulatory submission
- Write/maintain programs to produce diagnostics and listings for Data Management review
- Perform electronic data transfers (incoming/outgoing), including sample reconciliation; ensure transfer meets specifications
- Assist in developing statistical programming standards and data monitoring tools (visual analytics, patient profiles, programming checks)
- Create/document archives of software, outputs, and analysis files
- Review draft clinical reports, journal articles, slide presentations, and other documents for accurate reporting
- Support Statistical Programming leadership and provide time/resource estimates for planning
- Adhere to department/company policies; provide oversight to direct/indirect reports
Qualifications (Education/Experience):
- Bachelor’s degree in Biostatistics, Statistics, or related quantitative discipline; Master’s preferred
- At least 6 years of statistical programming experience in pharma/biotech/CRO
- Prior experience with SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL (Windows) to develop/validate analysis datasets, tables, listings, figures/graphs
- Experience with Integrated Summary Safety/Efficacy Analyses and NDA/BLA submissions (Hematology Oncology preferred)
Skills/Position Requirements:
- Knowledge of CDASH and CDISC standards (SDTM, ADaM)
- Knowledge of relational databases, GCP, and 21 CFR Part 11
- Familiarity with safety data and coding dictionaries (MedDRA, WHODD)
- Ability to create eCTD submission documents
- Ability to work independently, multi-task, and act innovatively
Application Instructions:
For more information, please see https://xencor.com/careers/.