Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Summary:
Senior Manager, Statistical Programming and Data Operations (SPDO) in Biostatistics is responsible for vendor oversight and management to deliver the high-quality tables, listings, and figures (TLFs), as well as CDISC datasets for clinical trials and integrated statistical analysis intended for regulatory submissions, interfacing with cross-regional staffs in establishing and maintaining global data standards and department procedures.
Essential Functions:
Vendor Oversight and Management
• Responsible for developing TLF shells, CDISC deliverables, and TLFs in collaboration with stat/programming vendors.
• Participate in vendor selection/oversight processes: Create and/or review Requests for Proposal (RFP); track the progress of stat/programming activities and the project budget for stat/programming vendor; and manage the timeline of stat/programming deliverables.
• Collaborate with stat/programming vendors to ensure all statistical deliverables from the vendor meet timelines with quality. Oversee all aspects of statistical programming tasks performed by the vendor.
• Manage the stat/programming related TMFs in collaboration with stat/programming vendors and act as a subject matter expert at FDA inspections.
Internal Collaboration
• Interface with in-house staff: Participate on project team meetings; and manage the cost and timeline of stat/programming activities in collaboration with each project manager.
• Review protocols, case report forms, statistical analysis plans, specifications for raw data, clinical study reports, and the other study-related documents.
• Collaborate with biostatistician to provide statistical programming input on project topics and issues.
Statistical Programming
• Responsible for preparation of CDISC data submission package and SAS programming for regulatory documents (e.g. 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 our Japanese colleagues, as needed, regarding global procedures, processes, and standards.
Requirements:
Education
Master’s Degree in Computer Science, Statistics, or closely related discipline.
Experience
· 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.
· Must have experience in data integration for ISS/ISE across multiple studies for regulatory submissions.
· Experience in using SAS-LSAF (i.e. Life Science Analytics Framework), including its repository and programming environment (preferred)
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It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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