Director, AI-Driven Standards & Biometrics Automation

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

Descrizione del lavoro

Neurocrine Biosciences is seeking a Director to lead the execution of Standards and Integration strategies with automation-centric, AI-enabled biometrics workflows across the clinical development portfolio. You will partner with Data Management, Biostatistics, and IT to create scalable, regulation-compliant data solutions and submission-ready outputs.

The role requires 15+ years in biotech/pharma with strong CDISC knowledge, SAS/R/Python/SQL skills, and proven vendor management.

Competenze

• 15+ years of biotech/pharma/clinical development experience in computer science, mathematics, statistics, or a related field, including leading teams.
• Deep knowledge of CDASH and CDISC standards (SDTM/ADaM/Define-XML) and regulatory data/submissions.
• Advanced SAS or R proficiency; Python and SQL strongly preferred.
• Experience with Medidata Rave EDC build and content reuse.
• Knowledge of GxP, data integrity and audit trails; collaboration with IT/Quality on validation.
• Proven success with end-to-end vendor management and outsourcing plans.
• Ability to work across Data Management, Biostatistics, Statistical Programming, Data Science, IT and Clinical Operations; act as a trusted advisor on standards and automation.
• This position could also be remote in California.

Mansioni

• Translate the Standards and Integration strategy into actionable priorities, execution plans and measurable outcomes; lead and develop the team.
• Improve foundational standards enabling automation and consistent execution across studies (standards rulesets, mappings, reusable templates, workflow checklists).
• Drive CDISC implementation with linkages from CDASH data collection to SDTM/ADaM and Neurocrine analyses.
• Oversee design and quality of submission outputs (Define-XML) with traceability and inspection readiness.
• Design, develop, validate and deploy low/no-code and programmatic automations (SAS, R, Python, SQL) including reusable macros and ETL workflows.
• Enable governed AI use within Biometrics with peer review and automated checks; provide training.
• Lead evaluation and lifecycle oversight of biometrics technologies with IT and Quality.
• Contribute to outsourcing plans and manage external vendors; develop SOPs and continuous improvement.
• Collaborate with Data Science, IT and other departments to generate integrated insights for decision-making.
• Identify new tools, technologies and methodologies; participate in industry standards bodies.

Conoscenze

Leadership

Cross-functional leadership

Automation

AI in analytics

SAS

R

Python

SQL

Vendor management

Formazione

PhD in a related field

Bachelor’s degree in a related field

Strumenti

Medidata Rave

Descrizione del lavoro

Neurocrine Biosciences is seeking a Director to lead the execution of Standards and Integration strategies with automation-centric, AI-enabled biometrics workflows across the clinical development portfolio. You will partner with Data Management, Biostatistics, and IT to create scalable, regulation-compliant data solutions and submission-ready outputs.

The role requires 15+ years in biotech/pharma with strong CDISC knowledge, SAS/R/Python/SQL skills, and proven vendor management.