Associate Director Biometrics Standards & Integrations

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:

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Your Contributions (include, but are not limited to):

• Implement and champion 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 and operationalization aligned to CDISC expectations, including strong a linkage between CDASH-compliant data collection and downstream CDISC-compliant data and subsequent Neurocrine standard analysis/reporting

• Support design and quality of submission-critical outputs, including the Define-XML package, ensuring traceability, consistency and an inspection-readiness mindset

• Build and deploy low/no-code automations that 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 (creating and implementing use cases, access restrictions, peer review, and automated checks)

• Define inspection-ready evidence for automated/AI-assisted outputs

• Provide training and technical support to end users for effective adoption and utilization of AI and automation solutions

• Shape, with buy-in and endorsement from ADS Leaders, the ADS technology strategy by guiding the adoption of innovative technologies and encouraging a culture of creativity and continuous improvement

• Drive innovation within biometrics by identifying and implementing new tools, technologies, and methodologies to enhance efficiency and effectiveness, while fostering collaboration with peers across relevant functional areas

• Other duties as assigned

Requirements:

• BS/BA degree AND 10+ years of relevant biotech/pharma/CRO clinical development experience

  OR

  Master’s degree AND 8+ years of related biotech/pharma/CRO clinical development experience

  OR

• PhD AND 5+ years of related biotech/pharma/CRO clinical development experience

• Considered an expert within the company and may have external presence in area of expertise

• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively

• Ability to work as part of and lead multiple teams

• Sees broader picture and longer-term impact on division/company

• Excellent leadership, coaching and development skills

• Strong negotiation and influencing skills

• Excellent communication, problem-solving, analytical thinking skills

• Excellent computer skills

• Excellent organizational and time management skills with the ability to work independently and in a team environment to meet established deadlines

• Deep knowledge of CDASH and CDISC industry standards (e.g., SDTM, ADaM, Define.xml) and the increasingly complex regulatory requirements for delivering regulatory quality data

• Experience leveraging standards to create processes that facilitate automation and AI-driven solutions to optimize Analytic and Data Sciences deliverables

• Advanced SAS or R proficiency; +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, audit trails, and partnering with IT/Quality on validation

#LI-RS1

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.

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