Executive Director, Biometrics Standards and Integration

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.

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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Create and implement department vision and strategic direction for Biometrics Standards and Integration, overseeing the automation of clinical data standards and processes from protocol finalization to final Tables, Figures, and Listings production

• Lead cross-functional teams to streamline clinical development systems through AI technologies and content reuse, collaborating with Data Science, IT, and other departments to generate insights from integrated data sources that drive strategic decision-making

• Oversee the long-term technical roadmap for designing and implementing company-wide automated data processing solutions, workflows using the latest statistical programming languages and standards to ensure data integrity and operational efficiency

• Create and execute strategic long-term workforce planning, ensuring optimal balance of resources (build/buy) while managing vendor partnerships from selection through performance monitoring

• Proactively research statistical system landscape by evaluating novel tools, ensuring scalability, and proposing strategies for clinical data and statistical software needs, while fostering a culture of continuous improvement and innovation

• Partner with external connections to influence industry standards and trends, proposing and implementing new strategies for standard operating procedures that maintain Neurocrine's competitive advantage

• Other duties as assigned

• BS/BA degree in a computer science, mathematics, statistics, or related field and 17+ years of experience in the biopharmaceutical or Contract Research Organizations (CRO) industry with extensive experience in a leadership role, leading teams of in-house and/or contract statistical programming or clinical data science management / staff OR

• Master's degree in a computer science, mathematics, statistics, or related field and 15+ years of similar experience noted above OR

• PhD in a computer science, mathematics, statistics, or related field

  and 12+ years of similar experience noted above

• Expert knowledge of industry systems landscape and proven ability to identify and evaluate potential systems for company use.

• Expertise in latest statistical programming skills and the development and implementation of statistical programming procedures and processes in a clinical development environment.

• In-depth knowledge of functional area, business strategies, and company goals, with demonstrated expertise in latest statistical programming, clinical development processes, AI technologies, and automation of data workflows

• Proven ability to work broadly across departments, interacting professionally with Data Science, IT, clinical operations, data management, and biostatistics to ensure seamless implementation of standards

• Advanced knowledge of regulatory guidelines and requirements relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data

• Advanced knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems

• Expert knowledge of Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets and the development of integrated databases

• Proven track record of delivering statistical analysis in supporting the drug development application process

• Extensive systems identification and evaluation experience

• Extensive experience in developing and managing strategic outsourcing plans, effectively collaborating with external vendors to ensure quality and timeliness of work products

• Acts as a "trusted advisor" across the company and may be recognized as an external expert

• Provides strategy, vision and direction regarding issues that may have company-wide impact

• Must be self-motivated and detail-oriented

• Ability to quickly learn and think independently

• Excellent leadership, coaching and employee development skills

• Advanced analytical thinking and judgment to evaluate and address key business/scientific challenges and drive strategic decision-making

• Exceptional interpersonal and communication skills, with the ability to lead, mentor, and develop a team of biometrics professionals. Able to interact professionally with peers, management, and leadership

• Excellent organizational and time management skills, capable of independently coordinating workload under pressure to meet established deadlines.

• Possesses industry-leading knowledge pertaining to clinical and regulatory aspects of a pharmaceutical company.

• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact

• Excellent interpersonal skills and problem-solving capabilities

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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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