Senior Manager, Statistical Programming

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🇺🇸 United States – Remote

💵 $150k - $224.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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

• 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

• 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