Sr. Director, Biometrics Standards and Integration

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 Biosciences is 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:

The Senior Director, Biometrics Standards and Integration will lead the innovative automation of clinical data standards and biometrics processes and infrastructure, from the finalization of study protocols to the complete production of final Tables, Figures, and Listings. This role entails broadly working cross-functionally to streamline and automate clinical development processes for systems and documents through clinical content reuse and AI technologies. The Senior Director will collaborate closely with Data Science, IT, and other departments to generate insights from integrated data sources, driving strategic decision-making. Additionally, the individual will develop and implement a strategic outsourcing plan to optimize biometrics operations. The Senior Director will maintain external connections to stay up-to-date with industry standards and actively contribute to and influence the evolution of these standards.

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

• Implement vision and strategic direction for Biometrics Standards and Integration, ensuring alignment with company goals and industry standards.

• Lead the automation of clinical data standards and biometrics processes and infrastructure, spanning from protocol finalization to the production of final Tables, Figures, and Listings.

• Work broadly across departments to streamline and automate clinical development systems and documents through clinical content reuse and AI technologies.

• Collaborate with Data Science, IT, and other departments to generate insights from integrated clinical and non-clinical data sources, driving strategic decision-making.

• Develop and implement a strategic outsourcing plan to optimize biometrics operations, ensuring an effective balance of in-house and outsourced resources.

• Maintain external connections to stay current with industry standards and trends, actively contributing to and influencing the evolution of clinical data standards.

• Design and build automated data processing workflows using statistical programming languages (SAS, R) to streamline data extraction, transformation, and loading (ETL) processes.

• Develop reusable macros and functions to optimize data manipulation and analysis tasks, ensuring efficiency and accuracy.

• Create data quality checks and alerts to identify potential data issues early in the process, maintaining high standards of data integrity.

• Oversee and monitor the statistical system landscape, evaluating novel tools for potential use, and ensuring scalability of systems and resourcing models.

• Ensure the company's clinical data and statistical software needs are met, overseeing the identification, acquisition, installation, validation, and maintenance of new software.

• Oversee long-term workforce planning for the department, ensuring the right balance of in-house and contract resources to support current and future corporate development programs.

• Manage all external vendors, from identification and selection to monitoring quality standards and timeliness, and ending relationships as needed.

• Implement and manage the development and revision of standard operating procedures.

• Build and maintain strong relationships with internal and external customers to ensure effective collaboration and support.

Requirements, Knowledge & Skills:

• BS/BA degree in a computer science, mathematics, statistics, or related field and 15+ 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.

• Master's degree in a computer science, mathematics, statistics, or related field and 13+ years of similar experience noted above OR

• PhD in a computer science, mathematics, statistics, or related field and 10+ years of similar experience noted above

• 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

• In-depth knowledge of functional area, business strategies, and company goals, with demonstrated expertise in SAS & R 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.

• 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

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

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

• 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

• Solid knowledge of SDTM and ADaM datasets and the development of integrated databases

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

• Proven success with end to end vendor management

• Extensive systems identification and evaluation experience

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

• Foster a culture of continuous improvement and innovation within the biometrics team and processes, leveraging AI and automation for optimal results.

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

• Strong understanding of regulatory guidelines and requirements, ensuring data quality, integrity, and compliance with industry standards.

• 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.

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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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The annual base salary we reasonably expect to pay is $223,700.00-$323,800.00. 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.