Remote Senior Manager, AI-Driven Statistical Programming

Otsuka America Pharmaceutical Inc.; Juneau (AK); Remote; USD 150,000 - 224,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials. You will work with the Statistical Programming team, cross-functional groups, and external vendors to ensure quality and regulatory compliance.

The role emphasizes AI-enabled programming, SDTM/ADaM, strategy development, and leadership across projects, with remote work options and a strong regulatory focus.

Qualifications

• Proficiency with SAS, R and AI-enabled tools to produce TFLs and datasets.
• Knowledge of CDISC standards and data structures.
• Experience with regulatory deliverables and define.xml, SDTM/ADaM.

Responsibilities

• Create SAS programs and AI-assisted solutions for end-to-end statistical programming including SDTM/ADaM.
• Validate programming outputs for accuracy and regulatory compliance.
• Develop strategies, standards and specifications for analyses and AI-enabled approaches.
• Lead submission preparations, regulatory responses, and vendor interactions.

Skills

SAS

R

AI-enabled programming tools

CDISC standards

regulatory deliverables

team collaboration

Education

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

Tools

MS Office

XML

Pinnacle 21

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials. You will work with the Statistical Programming team, cross-functional groups, and external vendors to ensure quality and regulatory compliance.

The role emphasizes AI-enabled programming, SDTM/ADaM, strategy development, and leadership across projects, with remote work options and a strong regulatory focus.