Sr. Principal Specialist, Clinical Database Programming

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:

Provides strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. This is a hands-on role, and accountable for defining standards, governance, and long-term strategy to ensure high-quality, compliant, and scalable clinical databases. Serves as a recognized expert, influencing cross-functional decision-making and driving continuous improvement, innovation, and inspection readiness across all therapeutic areas and development phases. _

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

Provide strategic leadership and functional ownership of clinical database programming across all clinical programs and therapeutic areas

Define, implement, and oversee standards, processes, and best practices for database programming to ensure consistency, quality, and regulatory compliance

Mentor, train, and develop team members (as required)

Lead and perform clinical database programming activities, including database build, data review and cleaning programs, validation and derivation procedures, database migrations, Targeted SDV configuration, SAS dataset creation, and Global Library maintenance, ensuring the highest standards of quality, compliance, and inspection readiness. Partner within Data Management and Analytics & Data Sciences (ADS) as well as cross-functional leadership to help develop long-arrange plans, resourcing, and operating models aligned with corporate objectives

Oversee database timelines, risks, and dependencies; proactively identify and mitigate complex technical/systemic issues that could impact quality, inspection readiness, or submissions

Oversee vendor quality and performance, including CROs and consultants, ensuring alignment with internal standards and expectations

Lead evaluation, implementation, validation, and adoption of new technologies, platforms, and system enhancements related to data collection, validation, integration, and review

Assess the impact of and oversee software updates, including impact to team processes and workflows, and document findings, risks, and recommended actions

Ensure inspection readiness and regulatory compliance through proactive oversight of SOPs, work instructions, documentation practices, and quality metrics

Act as a liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners

Stay current with industry trends and regulatory expectations; translate insights into actionable improvements for Neurocrine

Provide hands-on technical guidance and expertise in high-risk or high-complexity situations to ensure database quality and an appropriate resolution.

other duties as assigned

Requirements:

BS/BA degree AND 8+ years of relevant experience OR

Master’s AND 6+ years of related experience OR

PharmD or PhD AND 4+ years of related experience

Demonstrated success as a leader and influencing cross-functional teams without direct authority

Strong leadership, communication, problem-solving, and decision-making skills

Anticipates business and industry issues; recommends relevant process / technical / service improvements

Demonstrates broad expertise or unique knowledge

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

Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team

Ability to work as part of and lead multiple teams

Strong leadership, mentoring skills and abilities; typically leads lower levels and/or indirect teams

Excellent computer skills

Excellent communications, problem-solving, analytical thinking skills

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

Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

Excellent project management, strong project leadership skills

Advanced knowledge of Medidata Rave and clinical database programming within a pharmaceutical or biotechnology environment (CRO or sponsor)

Extensive understanding of the end-to-end drug development process and regulatory submission requirements

Expert knowledge of GCP and applicable FDA/EMA regulations and guidance

Demonstrated experience with CDISC standards (CDASH, SDTM) and organizational implementation of standards

Proven ability to define and govern SOPs, work instructions, and functional standards across the organization

Advanced hands-on experience with clinical database programming tools, including SAS and SQL (or other programming language)

Experience with data visualization tools

Experience leading enterprise-wide system implementations or major upgrades

Experience with custom programming a plus

#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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The annual base salary we reasonably expect to pay is $158,100.00-$216,000.00. 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.