Remote Senior Manager, AI-Driven Statistical Programming

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

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Manager of Statistical Programming to lead end-to-end programming for clinical trials, including SDTM/ADaM and AI-enabled deliverables.

You will guide collaborations across internal teams and external vendors to ensure compliant, high-quality outputs. The role emphasizes strategic leadership, validation of AI-assisted solutions, and oversight of submission readiness, with a strong focus on regulatory standards and data

Qualifications

• Proficiency in SAS, R and AI-enabled programming to produce derived analysis datasets and TFLs.
• Knowledge of CDISC standards, data structures, and industry data standards.
• Experience with submission deliverables such as ADaM datasets and define.xml.
• Ability to apply AI-enabled techniques within regulated environments.

Responsibilities

• Lead development and validation of TFLs and datasets for clinical trials.
• Create SAS programs and AI-assisted solutions for SDTM/ADaM content.
• Ensure quality, reproducibility, and regulatory compliance of outputs.
• Collaborate with cross-functional teams and external vendors.
• Support submission preparations and regulatory responses.
• Develop strategies, standards, and AI-enabled optimization approaches.
• Review planning documents to align with team objectives and programming needs.
• Mentor contract staff on programming standards and QA practices.

Skills

SAS

R

AI-enabled tools

CDISC standards

Pinnacle 21

define.xml

Regulatory deliverables

Team collaboration

Education

Master's degree

Tools

MS Office

XML

Pinnacle 21

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Manager of Statistical Programming to lead end-to-end programming for clinical trials, including SDTM/ADaM and AI-enabled deliverables.

You will guide collaborations across internal teams and external vendors to ensure compliant, high-quality outputs. The role emphasizes strategic leadership, validation of AI-assisted solutions, and oversight of submission readiness, with a strong focus on regulatory standards and data