Remote Senior Manager, AI-Driven Statistical Programming

Otsuka America Pharmaceutical Inc.

Topeka (KS)

Remote

USD 150,000 - 224,000

Full time

12 days ago

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Benefits offered by this job

Medical, dental, vision

401(k) match

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials, and to provide expertise in statistical programming across the team and vendors.

Responsibilities include SAS programs for SDTM/ADaM, AI-assisted solutions, programming strategy, submissions, and regulatory deliverables; you will supervise contract workers and promote AI-enabled efficiencies.

Qualifications

Proficient in SAS, R and AI-enabled programming tools to produce analysis datasets and TFLs.
Knowledge of CDISC standards, relational databases and data standards.
Experience with MS Office, XML, Pinnacle 21 and applying AI-enabled technologies.
Ability to deliver ADaM datasets and define.xml for regulatory submissions.
Strong understanding of regulatory and industry standards for AI in regulated settings.
Experience with drug development, clinical trials, statistics plans, and protocol designs.

Responsibilities

Create SAS programs and AI-assisted solutions for end-to-end programming activities (SDTM, ADaM, TFLs).
Perform programming validation to ensure accuracy, reproducibility, and traceability.
Provide programming support for projects, including strategies, specifications, and analyses.
Lead and participate in submission preparations, deliverables, and regulatory responses.
Review planning documents to align with objectives and programming needs.
Develop or review validation plans for programming deliverables.