Senior Manager, Statistical Programming

Otsuka Pharmaceutical Companies (U.S.)

. Lead and participate in development and validation of datasets, tables, figures, and listings supporting clinical trial analysis and reporting .

Posted 10/5/2026full-timeRemote • United StatesSenior💰 $150,034 - $224,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in SAS programming, AI-enabled programming tools, and regulatory compliance within clinical trial environments. Proficient in developing submission-ready datasets and leading programming initiatives that enhance quality and efficiency.

Highest-signal resume keywords

SAS ProgrammingAI-Enabled Programming ToolsCDISC StandardsRegulatory ComplianceStatistical Analysis Plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SASRADaM DatasetsStatistical AnalysisProgramming ValidationData Presentation PlansXMLPinnacle 21Quality ReviewsAutomation Improvements

Soft Skills

CollaborationLeadershipCommunicationProblem-SolvingGuidance

Tools & Technologies

MS OfficeAI-Assisted Programming SolutionsRelational Database StructuresEmerging AI Technologies

Certifications & Qualifications

Master's Degree in StatisticsBiostatisticsMathematicsComputer ScienceLife Sciences

Industry Keywords

Clinical TrialsDrug DevelopmentRegulatory StandardsMedical TerminologyPharmaceutical Industry

About the role

Key responsibilities & impact

Lead and participate in development and validation of datasets, tables, figures, and listings supporting clinical trial analysis and reporting
Create SAS programs and AI-assisted programming solutions for end-to-end statistical programming activities, including SDTM, ADaM, and TFL content
Perform programming validation and quality reviews of analysis datasets, programming outputs, and AI-generated deliverables
Provide programming support, strategies, standards, specifications, programmed analyses, and AI-enabled approaches for project teams
Lead or support submission preparations, deliverables, and regulatory responses
Review statistical analysis plans, data presentation plans, and data review plans for programming alignment and impact
Develop or review validation plans for programming deliverables
Interact with vendors on standards, conventions, specifications, file transfers, and AI-enabled programming practices
Ensure deliverable quality, regulatory compliance, and adherence to SOPs and working practices
Identify opportunities for efficiency, consistency, automation, and quality improvements
Independently lead programming assignments with minimal supervision
Lead or participate in process improvement, standards, automation, and AI adoption initiatives
Supervise contract workers and provide guidance on programming standards, quality expectations, and AI-enabled workflows
Evaluate, implement, and champion emerging AI-enabled programming capabilities while maintaining quality, traceability, and regulatory controls

Requirements

What you’ll need

Proficiency in SAS, R (preferable), and AI-enabled programming tools
Knowledge of CDISC standards, relational database structures, and industry data standards
Experience with MS Office, XML, Pinnacle 21, and emerging AI-enabled technologies
Ability to produce submission-ready ADaM datasets, define.xml files, reviewer guides, and other regulatory deliverables
Strong knowledge of regulatory, industry, and technology standards and requirements for AI-enabled tools in regulated environments
Knowledge of drug development, clinical trials, medical terminology, statistical analysis plans, and protocol designs
Ability to work with clinical team members, vendors, and cross-functional stakeholders
Ability to identify productivity, quality, consistency, and automation improvements
Ability to evaluate, validate, and oversee AI-generated outputs for accuracy, reproducibility, traceability, and compliance
Ability to support adoption of new technologies, standards, and AI-enabled programming practices
Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or equivalent preferred
At least 4 years of pharmaceutical industry experience preferred
Experience supporting rare disease therapeutic areas and/or PK/PD analyses preferred but not required

Benefits

Comp & perks

Comprehensive medical, dental, vision, and prescription drug coverage
Company-provided basic life insurance
Accidental death and dismemberment insurance
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
Generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Incentive opportunity