Senior Manager, Statistical Programming – AI-Driven Trials

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

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid time off & holidays

Job summary

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

The role emphasizes AI-enabled programming, SDTM/ADaM patterns, and strategic programming plans, supporting submissions and regulatory responses while mentoring staff and contractors.

Qualifications

• Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or equivalent preferred.
• At least 4 years of pharmaceutical industry experience preferred.
• Proficiency with SAS, R, and AI-enabled programming tools.

Responsibilities

• Lead and participate in development and validation of datasets, tables, figures, and listings (TFLs) for clinical trials.
• Provide programming support for project teams, including strategies, standards, and programmed analyses.
• Lead submission preparations, deliverables, and regulatory responses.
• Review planning documents to ensure alignment with objectives and clear programming requirements.
• Develop or review validation plans for programming deliverables.

Skills

SAS

R

AI-enabled programming

CDISC standards

ADaM

Education

Master's degree in Statistics/ Biostatistics/ Mathematics/ Computer Science/ Life Sciences

Tools

Pinnacle 21

XML

AI-enabled platforms

Job description

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

The role emphasizes AI-enabled programming, SDTM/ADaM patterns, and strategic programming plans, supporting submissions and regulatory responses while mentoring staff and contractors.