Director, AI-Driven Biometrics Standards & Automation

Neurocrine Biosciences, Inc.; San Diego (CA); Remoto; USD 156.000 - 296.000; Tempo pieno

Descrizione del lavoro

Neurocrine Biosciences seeks a senior leader to drive the Standards and Integration strategy for automation-centric biometrics workflows across the clinical portfolio. You will oversee data governance, AI-enabled tooling, and regulatory-compliant reporting while partnering with Data Management, Biostatistics, and IT to operationalize requirements.

Reporting to the Executive Director, you will manage a team of professionals, external vendors, and strategic outsourcing.

Competenze

• 15+ years of experience or Bachelor’s degree plus 12+ years in biotech/pharma data/clinical development
• Deep knowledge of CDASH/CDISC (SDTM/ADaM/Define-XML) and regulatory data submissions
• Advanced SAS or R proficiency with statistical program development and validation; Python and SQL preferred
• Experience with Medidata Rave EDC build and content reuse and downstream readiness
• Knowledge of GxP, data integrity, audit trails, and IT/Quality validation
• Proven end-to-end vendor management and outsourcing strategy development
• Ability to partner across Data Management, Biostatistics, Statistical Programming, Data Science, IT and Clinical Operations
• Experience enabling automation/AI-driven solutions to analytics deliverables
• Strong leadership, coaching, and communication skills
• Ability to manage cross-functional delivery and escalate issues effectively

Mansioni

• Translate strategy into operational priorities, plans and measurable outcomes
• Lead automation and AI-enabled biometrics workflows across studies
• Drive standards adherence for CDISC-compliant data and reports
• Oversee submission design and quality, including Define-XML and traceability
• Develop and deploy low/no-code and programmatic automations (SAS, R, Python, SQL)
• Manage external vendors and outsourcing plans
• Collaborate with Data Science, IT and other departments to derive insights
• Provide training and support to drive adoption of automation
• Ensure regulatory-compliance and inspection-readiness across outputs

Conoscenze

Leadership

Cross-functional collaboration

Strategic thinking

Excellent communication

Formazione

Bachelor's degree in CS/Statistics/related field

Strumenti

SAS

R

Python

SQL

Medidata Rave

Descrizione del lavoro

Neurocrine Biosciences seeks a senior leader to drive the Standards and Integration strategy for automation-centric biometrics workflows across the clinical portfolio. You will oversee data governance, AI-enabled tooling, and regulatory-compliant reporting while partnering with Data Management, Biostatistics, and IT to operationalize requirements.

Reporting to the Executive Director, you will manage a team of professionals, external vendors, and strategic outsourcing.