Associate Director Biometrics Standards & Integrations

Biopharma Careers; San Diego (CA); On-site; USD 190,000 - 235,000; Full time

Benefits offered by this job

Competitive annual bonus

Health benefits

Job summary

Neurocrine Biosciences seeks a senior biometrics leader to scale automation-driven data management, programming and biostatistics workflows under regulatory compliance. You will partner with Data Management, Statistical Programming and Biostatistics to create reusable metadata and governance while enabling AI-enabled solutions.

Lead multiple teams, drive CDISC adoption, ensure inspection readiness, and shape ADS technology strategy with leadership buy-in.

Qualifications

• BS/BA degree AND 10+ years of relevant biotech/pharma/CRO clinical development experience
• Master’s degree AND 8+ years of related biotech/pharma/CRO clinical development experience
• PhD AND 5+ years of related biotech/pharma/CRO clinical development experience

Responsibilities

• Implement and enhance automation standards in data management and reporting workflows.
• Drive CDISC alignment including CDASH data collection and downstream Define/XML reporting.
• Develop low/no-code automations to improve consistency and inspection readiness.
• Define inspection-ready evidence for automated outputs and AI-assisted analyses.
• Provide training to end users on AI and automation adoption.

Skills

Leadership

SAS

Python

SQL

Biotech experience

Regulatory knowledge

Education

BS/BA degree

Master's degree

PhD

Tools

Medidata Rave EDC

Define.xml tooling

SAS

Job description

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook . ( *in collaboration with AbbVie )

About the Role:

Responsible to execute on strategy to scale and accelerate biometrics deliverables by leveraging existing standards and processes to implement automation-centric, AI-enabled workflows that result in regulatory compliant data collection, analysis, and reporting. This role works closely with project leads in Data Management, Statistical Programming and Biostatistics to operationalize existing data and analysis requirements into automation-centric, AI-enabled workflows in a regulatory compliant framework deeply rooted in reusable metadata, lifecycle governance, content reuse and responsible‑AI controls. This role will identify opportunities and partner with leadership to prioritize and design tools that facilitate seamless integration among Data Management, Statistical Programming and Biostatistics to scale and support a growing portfolio and ensure regulatory compliance and inspection readiness.

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

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 $171,800.00-$235,000.00. 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 30% 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.