Senior Manager, AI-Driven Statistical Programming

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

Benefits offered by this job

Medical benefits

Dental insurance

Vision insurance

401(k) match

Tuition reimbursement

Student loan assistance

Generous paid time off

Paid holidays

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Statistical Programmer to lead development and validation of TFLs for clinical trials, collaborating across Statistical Programming, cross-functional teams, and external vendors.

Responsibilities include end-to-end programming for SDTM/ADaM, strategy development, and contributing to submissions with robust QA, AI-enabled programming, and regulatory-compliant outputs.

Qualifications

• Proficiency in SAS, R and AI-enabled programming to produce derived analysis datasets and TFLs.
• Knowledge of CDISC standards, relational databases and industry data standards.
• Experience with software tools (MS Office, XML, Pinnacle 21) and adopting AI-enabled tech in regulated environments.
• Ability to deliver outputs meeting submission requirements (ADaM datasets, define.xml, reviewer guides).

Responsibilities

• Lead end-to-end statistical programming activities for SDTM/ADaM and TFL content.
• Validate programming outputs for accuracy, reproducibility and regulatory readiness.
• Support project teams with programming strategies, standards, and AI-enabled approaches.
• Lead submission preparations, regulatory responses, and vendor interactions.

Skills

SAS

R

AI tools

CDISC

ADaM

Regulatory

Team collaboration

Programming validation

Education

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

Tools

Pinnacle 21

MS Office

XML

Job description

Otsuka Pharmaceutical Co., Ltd. seeks a Senior Statistical Programmer to lead development and validation of TFLs for clinical trials, collaborating across Statistical Programming, cross-functional teams, and external vendors.

Responsibilities include end-to-end programming for SDTM/ADaM, strategy development, and contributing to submissions with robust QA, AI-enabled programming, and regulatory-compliant outputs.