Kyowa Kirin, Inc.- U.S.
Kyowa Kirin North America is a specialty pharmaceutical company dedicated to making a profound impact on patient lives.
Oncology • Oncology Supportive Care • Immunotherapy • Parkinson's Disease • Central Nervous System
501 - 1000
Senior Manager, Pharmaceutical Statistical Programming and Data Operations
August 9
🏢 In-office - Utica
Kyowa Kirin, Inc.- U.S.
Kyowa Kirin North America is a specialty pharmaceutical company dedicated to making a profound impact on patient lives.
Oncology • Oncology Supportive Care • Immunotherapy • Parkinson's Disease • Central Nervous System
501 - 1000
Description
• Responsible for vendor oversight and management to deliver high-quality tables, listings, and figures (TLFs), as well as CDISC datasets for clinical trials and integrated statistical analysis intended for regulatory submissions. • Collaborate with stat/programming vendors to ensure all statistical deliverables meet timelines with quality. • Manage the stat/programming related TMFs in collaboration with vendors and act as a subject matter expert at FDA inspections.
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. • 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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