Senior Manager, AI-Driven Statistical Programming

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Paid holidays

Paid leave

Job summary

Otsuka America Pharmaceutical, Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials, collaborate with cross-functional teams, and oversee AI-enabled programming efforts.

You will guide strategies, standards, and regulatory deliverables while ensuring quality and traceability. Responsibilities include end-to-end programming (SDTM/ADaM), validation, vendor interactions, and driving automation and efficiency across the function.

Qualifications

• Proficient in SAS, R and AI-enabled programming to produce SDTM/ADaM datasets and TFLs.
• Knowledge of CDISC standards and data standards.
• Experience with regulatory deliverables and tools.
• Ability to lead programming strategies, standards, and AI-enabled approaches.

Responsibilities

• Create SAS programs and AI-assisted solutions for end-to-end statistical programming (SDTM, ADaM, TFLs).
• Perform validation and quality review to ensure accuracy and traceability of outputs.
• Lead programming support for project teams and regulatory submissions.
• Interact with vendors on standards, conventions, and AI-enabled practices.
• Lead process improvements and automation within Statistical Programming.

Skills

SAS

R

AI tools

Regulatory knowledge

Team collaboration

Education

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

Tools

Pinnacle 21

define.xml

MS Office

XML

Job description

Otsuka America Pharmaceutical, Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials, collaborate with cross-functional teams, and oversee AI-enabled programming efforts.

You will guide strategies, standards, and regulatory deliverables while ensuring quality and traceability. Responsibilities include end-to-end programming (SDTM/ADaM), validation, vendor interactions, and driving automation and efficiency across the function.