Director, Standards & Integrations

Neurocrine Biosciences; San Diego (CA); Remote; USD 156,000 - 296,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Cross-functional leadership

Automation

AI in analytics

SAS

R

Python

SQL

Vendor management

Education

PhD in a related field

Bachelor’s degree in a related field

Tools

Medidata Rave

Job description

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About The Role

The role will lead the execution of the Standards and Integration strategy through automation-centric, AI-enabled biometrics workflows that scale and accelerate delivery across the clinical development portfolio, from protocol finalization through final Tables, Figures, and Listings (TFLs). Grounded in reusable metadata, lifecycle governance, content reuse and responsible-AI controls, this role ensures regulatory-compliant data collection, analysis, and reporting and sustained inspection readiness.

The Director partners closely with Data Management, Statistical Programming, Biostatistics, Data Science, IT and Quality to operationalize data and analysis requirements into integrated workflows and to design tools that enable seamless handoffs across functions. Reporting to the Executive Director, the role leads a team of standards and automation professionals, including subordinate leaders, manages strategic outsourcing and external vendors, and maintains external connections to stay current with, and helps shape, industry standards.

Your Contributions (include, But Are Not Limited To)

• Translate the Standards and Integration strategy into operational priorities, execution plans and measurable outcomes aligned with company goals and ADS leadership; lead, coach and develop the team, including subordinate leaders
• Lead continuous improvement of foundational standards that enable automation and consistent execution across studies (e.g., standards rulesets, mappings, reusable templates, workflow checklists, and controlled specifications)
• Drive standards implementation aligned to CDISC expectations, with strong linkage between CDASH-compliant data collection, downstream CDISC-compliant SDTM/ADaM data, and Neurocrine standard analysis and reporting
• Submission readiness: Oversee design and quality of submission-critical outputs, including the Define-XML package, ensuring traceability, consistency and an inspection-readiness mindset
• Lead the design, development, validation and deployment of low/no-code and programmatic (SAS, R, Python, SQL) automations, including reusable macros and functions, ETL workflows, and data quality checks and alerts, which improve:
  • Standards adherence and consistency
  • Handoff quality between Data Management, Statistical Programming and Biostatistics
  • Repeatability of analysis and reporting workflows
  • Inspection readiness through controlled outputs and documentation
• Enable governed AI use within Biometrics (use cases, access restrictions, peer review, and automated checks); define inspection-ready evidence for automated and AI-assisted outputs; and provide training and technical support to drive adoption
• Contribute to ADS technology strategy; lead evaluation, implementation and lifecycle oversight of assigned biometrics technologies, including software identification, acquisition, validation and maintenance, in partnership with ADS leadership, IT and Quality
• Lead implementation, adoption and sustained use of standards and automation solutions across Data Management, Statistical Programming and Biostatistics; monitor performance and resolve cross-functional delivery issues
• Collaborate with Data Science, IT and other departments to generate insights from integrated clinical and non-clinical data sources that inform strategic decision-making
• Develop and execute outsourcing plans within approved priorities and resource allocations; manage external vendors from selection through quality and timeliness oversight
• Contribute to long-term workforce planning and manage the development and revision of standard operating procedures
• Identify and implement new tools, technologies and methodologies; foster a culture of continuous improvement; and contribute to industry standards bodies and forums

Requirements

• 15+ years of experience or Bachelors Degree AND 12+ years of relevant biotech/pharma/CRO clinical development experience in computer science, mathematics, statistics, or a related field, including experience leading in-house and/or contract teams. OR
• PhD AND 8+ years of relevant experience as outlined above
• Deep knowledge of CDASH and CDISC standards (e.g., SDTM, ADaM, Define-XML) and of the increasingly complex regulatory requirements for delivering regulatory-quality data and submissions
• Advanced SAS or R proficiency, including development and validation of statistical programs and integrated programming libraries; Python and SQL strongly preferred
• Experience with Medidata Rave EDC build and content reuse (CRF standards, edit checks, libraries) and downstream readiness
• Deep knowledge of GxP expectations, data integrity and audit trails, and experience partnering with IT/Quality on validation
• Proven success with end-to-end vendor management and with developing and managing strategic outsourcing plans
• Proven ability to work across Data Management, Biostatistics, Statistical Programming, Data Science, IT and Clinical Operations; acts as a trusted advisor on standards and automation
• Experience identifying and evaluating systems and tools for company use
• Experience leveraging standards to create processes that enable automation and AI-driven solutions to improve Analytics and Data Sciences deliverables
• Excellent leadership, coaching, communication and people skills, with the ability to lead, mentor and develop a team and to engage peers and senior leadership
• Strong analytical judgment and the ability to complete complex, ambiguous initiatives with cross-functional impact; initiative-taking and meticulous
• This position could also be remote California.

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $155,500.00-$296,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.