Senior Manager, AI-Driven Statistical Programming

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 150,000 - 224,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

Prescription drug coverage

Basic life insurance

AD&D

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, Statistical Programming to lead development and validation of datasets, tables, figures, and listings for clinical trials. You will collaborate with the Statistical Programming team, cross-functional groups, and external vendors to ensure high-quality deliverables.

The role requires expertise in SAS, R (preferred), and AI-enabled programming, with a focus on regulatory compliance and efficient, scalable processes.

Qualifications

• Demonstrate proficiency in using SAS, R (preferrable), and AI-enabled programming tools to produce derived analysis datasets and TFLs
• Knowledge of CDISC standards, relational database structures, and industry data standards.
• Experience using software tools and applications (e.g., MS Office, XML, Pinnacle 21) and the ability to effectively adopt and apply emerging AI-enabled technologies
• Ability to provide outputs that meet submission requirements, including ADaM datasets, define.xml files, reviewer guides, and other regulatory deliverables
• Strong knowledge of regulatory, industry, and technology standards and requirements, including the appropriate use of AI-enabled tools in regulated environments
• Good knowledge of the drug development process, clinical trials, medical terminology, statistical analysis plans, and protocol designs
• Ability to work effectively in a team environment with clinical team members, vendors, and cross-functional stakeholders
• Demonstrated ability to identify opportunities to improve productivity, quality, consistency, and automation through innovative programming approaches and AI-enabled solutions
• Ability to critically evaluate, validate, and oversee AI-generated outputs to ensure accuracy, reproducibility, traceability, and compliance with established standards and procedures
• Ability to support and influence the adoption of new technologies, standards, and AI-enabled programming practices across project teams
• Experience supporting rare disease therapeutic areas and/or PK/PD analyses, preferred but not required
• Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or equivalent preferred, with at least 4 years of pharmaceutical industry experience preferred

Responsibilities

• Create SAS programs and AI-assisted programming solutions to perform end-to-end statistical programming activities including SDTM, ADaM, and content for TFLs
• Perform programming validation and quality review to ensure the accuracy, reproducibility, and integrity of analysis datasets, programming outputs, and AI-generated deliverables
• Provide programming support for project teams, including development of programming strategies, standards, specifications, programmed analyses, and AI-enabled programming approaches
• Lead and/or support submission preparations, deliverables, and regulatory responses
• Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; assess impact on programming activities
• Develop or review validation plans for programming deliverables to ensure quality and consistency of outputs
• Interact with vendors regarding project standards, programming conventions, programming specifications, file transfers, and AI-enabled programming practices, as applicable
• Provide leadership in ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and working practices.
• Identify opportunities for increased efficiency, consistency, automation, and quality within Statistical Programming and interactions with vendors through innovative programming approaches and appropriate use of AI-enabled technologies
• Independently lead and perform programming assignments with minimal supervision
• Lead and/or participate in process improvement, standards, automation, and AI adoption initiatives that enhance productivity, quality, scalability, and consistency across Statistical Programming
• Supervise contract workers and provide guidance on programming standards, quality expectations, and effective use of AI-enabled programming tools and workflows
• Evaluate, implement, and champion emerging AI-enabled programming capabilities to streamline workflows, accelerate deliverable development, and drive continuous improvement while maintaining appropriate quality, traceability, and regulatory controls

Skills

SAS

R (preferred)

AI-enabled programming tools

Education

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

Tools

MS Office

XML

Pinnacle 21

Job description

Otsuka Pharmaceutical Companies (U.S.) is seeking a Senior Manager, Statistical Programming to lead development and validation of datasets, tables, figures, and listings for clinical trials. You will collaborate with the Statistical Programming team, cross-functional groups, and external vendors to ensure high-quality deliverables.

The role requires expertise in SAS, R (preferred), and AI-enabled programming, with a focus on regulatory compliance and efficient, scalable processes.