Sr. Principal Specialist, Clinical Database Programming
Neurocrine Biosciences
June 27, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About the Role
Provides strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. Hands-on role accountable for defining standards, governance, and long-term strategy to ensure high-quality, compliant, and scalable clinical databases.
Your Contributions (include, but are not limited to)
- Provide strategic leadership and functional ownership of clinical database programming across clinical programs and therapeutic areas.
- Define, implement, and oversee standards, processes, and best practices for database programming for consistency, quality, and regulatory compliance.
- Mentor, train, and develop team members.
- Lead and perform database programming activities (database builds, data review/cleaning, validation/derivation, migrations, Targeted SDV configuration, SAS dataset creation, Global Library maintenance).
- Partner with Data Management and Analytics & Data Sciences (ADS) and cross-functional leaders on plans, resourcing, and operating models.
- Oversee database timelines, risks, dependencies; identify/mitigate technical issues impacting quality, inspection readiness, or submissions.
- Oversee vendor quality/performance (CROs/consultants).
- Evaluate, implement, validate, and adopt new technologies/platforms for data collection/validation/integration/review.
- Assess software update impacts and document risks/actions.
- Ensure inspection readiness and regulatory compliance via SOP/work instruction/documentation/quality metrics oversight.
- Liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners.
Requirements
- BS/BA + 8+ years OR Master’s + 6+ years OR PharmD/PhD + 4+ years related experience.
- Leadership/influencing cross-functional teams without direct authority.
- Advanced knowledge: Medidata Rave; clinical database programming; end-to-end drug development and regulatory submission requirements.
- Expert GCP and applicable FDA/EMA guidance; CDISC (CDASH, SDTM) and organizational implementation.
- Proven ability to define/govern SOPs and standards.
- Advanced hands-on SAS and SQL (or other programming language).
- Excellent computer skills; strong communication/problem-solving/analytical skills; strong project management.
- Experience with data visualization tools; enterprise system implementations/major upgrades.
Preferred
- Custom programming experience.
Benefits (if offered in description)
- Annual bonus (target 30%); equity long-term incentive eligibility; retirement savings match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Provides strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. Hands-on role accountable for defining standards, governance, and long-term strategy to ensure high-quality, compliant, and scalable clinical databases.
Your Contributions (include, but are not limited to)
- Provide strategic leadership and functional ownership of clinical database programming across clinical programs and therapeutic areas.
- Define, implement, and oversee standards, processes, and best practices for database programming for consistency, quality, and regulatory compliance.
- Mentor, train, and develop team members.
- Lead and perform database programming activities (database builds, data review/cleaning, validation/derivation, migrations, Targeted SDV configuration, SAS dataset creation, Global Library maintenance).
- Partner with Data Management and Analytics & Data Sciences (ADS) and cross-functional leaders on plans, resourcing, and operating models.
- Oversee database timelines, risks, dependencies; identify/mitigate technical issues impacting quality, inspection readiness, or submissions.
- Oversee vendor quality/performance (CROs/consultants).
- Evaluate, implement, validate, and adopt new technologies/platforms for data collection/validation/integration/review.
- Assess software update impacts and document risks/actions.
- Ensure inspection readiness and regulatory compliance via SOP/work instruction/documentation/quality metrics oversight.
- Liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners.
Requirements
- BS/BA + 8+ years OR Master’s + 6+ years OR PharmD/PhD + 4+ years related experience.
- Leadership/influencing cross-functional teams without direct authority.
- Advanced knowledge: Medidata Rave; clinical database programming; end-to-end drug development and regulatory submission requirements.
- Expert GCP and applicable FDA/EMA guidance; CDISC (CDASH, SDTM) and organizational implementation.
- Proven ability to define/govern SOPs and standards.
- Advanced hands-on SAS and SQL (or other programming language).
- Excellent computer skills; strong communication/problem-solving/analytical skills; strong project management.
- Experience with data visualization tools; enterprise system implementations/major upgrades.
Preferred
- Custom programming experience.
Benefits (if offered in description)
- Annual bonus (target 30%); equity long-term incentive eligibility; retirement savings match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.