Remote AI-Driven Senior Manager, Statistical Programming

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

Benefits offered by this job

Comprehensive medical

Dental coverage

Vision coverage

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials and guide AI-enabled programming strategies.

You will collaborate with the Statistical Programming team, cross-functional partners, and external vendors. This remote, full-time role requires expertise in SAS, R, CDISC standards, and ADaM/SDTM, with strong leadership to ensure data integrity, regulatory compliance, and high-quality deliverables across

Qualifications

• Master's degree in Statistics/Biostatistics or related field.
• 4+ years pharmaceutical industry experience preferred.
• Proficient in SAS and R.
• Experience with ADaM/SDTM datasets and TFLs.
• Familiar with AI-enabled programming tools.
• Strong regulatory and cross-functional collaboration skills.

Responsibilities

• Create SAS programs and AI-assisted programming solutions for SDTM/ADaM and TFLs.
• Lead validation and quality review for datasets and outputs.
• Provide programming support and strategies across projects.
• Lead submission preparations and regulatory responses.
• Review planning documents to ensure alignment and clarity of programming assumptions.
• Develop or review validation plans for programming deliverables.
• Interact with vendors on standards and AI practices.
• Lead process improvements and AI adoption initiatives.
• Supervise contract workers and mentor juniors in programming.
• Champion emerging AI-enabled capabilities while maintaining compliance.

Skills

SAS

R

AI tools

Leadership

Education

Master's degree in Statistics / Biostatistics / CS

Tools

SAS

Pinnacle 21

SQL

Job description

Otsuka America Pharmaceutical, Inc. seeks a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials and guide AI-enabled programming strategies.

You will collaborate with the Statistical Programming team, cross-functional partners, and external vendors. This remote, full-time role requires expertise in SAS, R, CDISC standards, and ADaM/SDTM, with strong leadership to ensure data integrity, regulatory compliance, and high-quality deliverables across