Senior Statistical Programming Lead - AI-Driven, Remote

Otsuka America Pharmaceutical Inc.

Austin (TX)

Remote

USD 150,000 - 224,000

Full time

12 days ago

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Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Tuition reimbursement

Paid holidays and paid leave

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead the development and validation of datasets, tables, figures, and listings (TFLs) for clinical trials and to provide expert programming guidance across SDTM/ADaM and AI-enabled methods.

You will collaborate with cross-functional teams and vendors, write SAS programs, validate outputs, support regulatory submissions, and drive process improvements while ensuring quality, traceability, and compliance

Qualifications

Proficient in SAS, R (preferred) and AI-enabled programming tools for SDTM/ADaM and TFLs.
Knowledge of CDISC standards and data structures.
Experience with regulatory deliverables and submission datasets (define.xml, reviewer guides).
Ability to implement AI-enabled programming within regulated environments.

Responsibilities

Lead end-to-end statistical programming activities including SDTM, ADaM, and TFL content.
Perform programming validation to ensure accuracy, reproducibility, and regulatory readiness.
Develop programming strategies, standards, and specifications for analyses and AI-enabled approaches.
Lead submissions, regulatory responses and audit-ready deliverables.
Collaborate with cross-functional teams and external vendors to ensure quality and timelines.
Identify opportunities to improve productivity and automation via AI-enabled solutions.
Supervise contract workers and provide guidance on programming standards and quality expectations.