Senior Manager, Pharmaceutical Statistical Programming and Data Operations

1 week ago

Princeton, New Jersey, United States Kyowa Kirin, Inc. Full time
Job Summary

Kyowa Kirin, a global specialty pharmaceutical company, seeks a Senior Manager, Pharmaceutical Statistical Programming and Data Operations to oversee vendor management and ensure high-quality deliverables for clinical trials and regulatory submissions.

Key Responsibilities
  • Develop TLF shells, CDISC deliverables, and TLFs in collaboration with stat/programming vendors.
  • Participate in vendor selection/oversight processes, including creating and reviewing RFPs, tracking vendor progress, and managing project timelines and budgets.
  • Collaborate with vendors to ensure statistical deliverables meet timelines and quality standards, overseeing all aspects of statistical programming tasks.
  • Manage stat/programming related TMFs and serve as a subject matter expert at FDA inspections.
Internal Collaboration
  • Interface with in-house staff, participating in project team meetings and managing cost and timeline of stat/programming activities.
  • Review protocols, case report forms, statistical analysis plans, specifications for raw data, clinical study reports, and other study-related documents.
  • Collaborate with biostatisticians to provide statistical programming input on project topics and issues.
Statistical Programming
  • Prepare CDISC data submission packages and SAS programming for regulatory documents, such as Response to Information Requests from HA, Integrated Summaries, BIMO, and DSUR.
  • Provide statistical programming for publications and presentations, ad-hoc and post-hoc analyses of clinical study data.
  • Conduct programming QC reviews of vendor deliverables in accordance with internal guidelines and work instructions.
  • Support departmental initiatives related to process building/improvement of programming activities.
  • Coordinate and liaise with Japanese colleagues regarding global procedures, processes, and standards.
Requirements
  • Master's Degree in Computer Science, Statistics, or closely related discipline.
  • Minimum eight (8) years' experience in statistical programming for clinical trials in the life science industry.
  • Demonstrated expertise in CDISC standards and CDISC compliant submission requirements.
  • Experience in data integration for ISS/ISE across multiple studies for regulatory submissions.
  • Experience in using SAS-LSAF, including its repository and programming environment (preferred).

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