Sr. Principal Specialist, Clinical Database Programming
Neurocrine Biosciences
August 09, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About the Role
Strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. Hands-on role accountable for standards, governance, and long-term strategy to ensure high-quality, compliant, scalable clinical databases; recognized expert influencing cross-functional decisions and driving improvement and inspection readiness.
Responsibilities
- Provide strategic leadership and functional ownership of clinical database programming across programs/therapeutic areas.
- Define, implement, and oversee standards, processes, and best practices for database programming.
- Mentor/train team members (as required).
- Lead hands-on database programming: database build, review/cleaning, validation and derivation, migrations, Targeted SDV configuration, SAS dataset creation, and Global Library maintenance; partner with Data Management and Analytics & Data Sciences (ADS) and cross-functional leadership on plans/resourcing.
- Oversee database timelines, risks, dependencies; identify/mitigate technical/systemic issues impacting quality or submissions.
- Oversee vendor quality/performance (CROs/consultants).
- Evaluate/implement/validate/adopt new technologies and system enhancements (data collection/validation/integration/review).
- Assess software update impacts; document findings, risks, and actions.
- Ensure inspection readiness and regulatory compliance via SOPs, work instructions, documentation practices, and quality metrics.
- Liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners.
- Stay current on industry/regulatory expectations; translate to actionable improvements.
- Provide technical guidance in high-risk/high-complexity situations.
Requirements
- BS/BA + 8+ yrs OR Master’s + 6+ yrs OR PharmD/PhD + 4+ yrs.
- Leadership and cross-functional influence without direct authority.
- Advanced Medidata Rave and clinical database programming experience (CRO or sponsor); end-to-end drug development/regulatory submission knowledge.
- Expert GCP; FDA/EMA regulations; CDISC (CDASH, SDTM).
- Ability to define/govern SOPs and work instructions.
- Advanced SAS and SQL (or other language); data visualization tools; enterprise implementations/upgrades.
- Excellent communication, problem-solving, analytical thinking, project management.
Benefits
- Annual bonus (target 30%) and eligibility for equity long-term incentive; retirement plan with company match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.
Strategic and operational leadership for the clinical database programming function across Neurocrine’s clinical development portfolio. Hands-on role accountable for standards, governance, and long-term strategy to ensure high-quality, compliant, scalable clinical databases; recognized expert influencing cross-functional decisions and driving improvement and inspection readiness.
Responsibilities
- Provide strategic leadership and functional ownership of clinical database programming across programs/therapeutic areas.
- Define, implement, and oversee standards, processes, and best practices for database programming.
- Mentor/train team members (as required).
- Lead hands-on database programming: database build, review/cleaning, validation and derivation, migrations, Targeted SDV configuration, SAS dataset creation, and Global Library maintenance; partner with Data Management and Analytics & Data Sciences (ADS) and cross-functional leadership on plans/resourcing.
- Oversee database timelines, risks, dependencies; identify/mitigate technical/systemic issues impacting quality or submissions.
- Oversee vendor quality/performance (CROs/consultants).
- Evaluate/implement/validate/adopt new technologies and system enhancements (data collection/validation/integration/review).
- Assess software update impacts; document findings, risks, and actions.
- Ensure inspection readiness and regulatory compliance via SOPs, work instructions, documentation practices, and quality metrics.
- Liaison across Clinical Data Management (and ADS), Clinical Operations, DSPV, Regulatory, IT, and external partners.
- Stay current on industry/regulatory expectations; translate to actionable improvements.
- Provide technical guidance in high-risk/high-complexity situations.
Requirements
- BS/BA + 8+ yrs OR Master’s + 6+ yrs OR PharmD/PhD + 4+ yrs.
- Leadership and cross-functional influence without direct authority.
- Advanced Medidata Rave and clinical database programming experience (CRO or sponsor); end-to-end drug development/regulatory submission knowledge.
- Expert GCP; FDA/EMA regulations; CDISC (CDASH, SDTM).
- Ability to define/govern SOPs and work instructions.
- Advanced SAS and SQL (or other language); data visualization tools; enterprise implementations/upgrades.
- Excellent communication, problem-solving, analytical thinking, project management.
Benefits
- Annual bonus (target 30%) and eligibility for equity long-term incentive; retirement plan with company match; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision coverage.