Senior Statistical Programming Lead - AI-Driven

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 150,000 - 224,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Manager of Statistical Programming to lead SDTM/ADaM programming and TFLs for clinical trial analysis. You will collaborate with cross-functional teams and external vendors to ensure regulatory-ready outputs.

Responsibilities include developing programming strategies, validating outputs, and advancing AI-enabled programming practices while maintaining traceability and compliance.

Qualifications

• Proficiency in SAS and R; experience with AI-enabled programming tools.
• Knowledge of CDISC standards, data standards and RDMS concepts.
• Ability to produce ADaM datasets, define.xml and submission-ready deliverables.

Responsibilities

• Lead end-to-end statistical programming activities for SDTM/ADaM and TFLs.
• Perform programming validation and quality review for accuracy and traceability.
• Develop programming strategies, standards, and AI-enabled approaches for project teams.

Skills

SAS

R

AI-enabled tools

Data analysis

Education

Master's degree in Statistics/Biostatistics/Math/CS

Tools

MS Office

Pinnacle 21

XML

Job description

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Manager of Statistical Programming to lead SDTM/ADaM programming and TFLs for clinical trial analysis. You will collaborate with cross-functional teams and external vendors to ensure regulatory-ready outputs.

Responsibilities include developing programming strategies, validating outputs, and advancing AI-enabled programming practices while maintaining traceability and compliance.