Associate Director, Statistical Programming
Neurocrine Biosciences
August 07, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Program Lead Statistical Programmer on one or more clinical programs; provides statistical programming leadership and strategic input to plans/objectives. Builds efficient, fit-for-purpose early-phase analysis approaches. Provides guidance on analysis, reporting, regulatory submission deliverables, and programming standards/tools/processes. Partners cross-functionally to ensure high-quality, scalable delivery; may have direct reports.
Your Contributions (include, But Are Not Limited To)
- Lead statistical programming for one or more clinical programs; set expectations and scalable ways of working.
- Serve as clinical program lead statistical programmer across the development lifecycle (early-phase/POC).
- Develop/implement fit-for-purpose approaches for analysis, reporting, and regulatory submission deliverables (e.g., annotated CRFs, dataset transport files, define documents, reviewer guides).
- Create frameworks for strategy, resourcing, analysis, and delivery; improve processes/technology.
- Build expertise in specialized clinical data/study considerations (e.g., PK/PD, biomarkers, labs, healthy volunteers, special populations).
- Lead programming standards/conventions; develop statistical programming infrastructure.
- Plan/assess workload and resourcing; hire/train/coach/oversee in-house and contract programmers.
- Assess software needs; manage/validate external vendor programming (e.g., CDISC implementation, analysis reporting).
- Create/validate e-submission requirements.
- Lead agency reporting deliverables (DSUR/Annual Report, IB updates); act as lead and/or QC programmer as needed.
Requirements
- BS/BA + 10+ yrs, OR Master’s + 8+ yrs, OR PhD + 6+ yrs as a statistical programmer in biopharma/CRO with advanced SAS (Base/Stat/Macro/graph); plus prior managerial/functional management experience.
- Thought leadership; broad functional process understanding; advanced relational databases/complex data systems.
- Cross-functional leadership; strong coaching, organization, time management, and communication.
- Proficiency: Microsoft Office (Word/Excel/PowerPoint).
- Working knowledge: SDTM/ADaM; integrated databases.
- Knowledge: regulatory requirements for dataset submissions (SAS and CDISC); writing/validating/documenting statistical programs; integrated programming libraries.
- Strong negotiation/influencing; excellent project management.
Compensation/Benefits (as stated)
- Annual base salary: $171,800.00–$235,000.00; target annual bonus 30% of earned base; equity long-term incentive eligibility.
- Retirement plan (company match), paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/prescription/dental/vision coverage.
Program Lead Statistical Programmer on one or more clinical programs; provides statistical programming leadership and strategic input to plans/objectives. Builds efficient, fit-for-purpose early-phase analysis approaches. Provides guidance on analysis, reporting, regulatory submission deliverables, and programming standards/tools/processes. Partners cross-functionally to ensure high-quality, scalable delivery; may have direct reports.
Your Contributions (include, But Are Not Limited To)
- Lead statistical programming for one or more clinical programs; set expectations and scalable ways of working.
- Serve as clinical program lead statistical programmer across the development lifecycle (early-phase/POC).
- Develop/implement fit-for-purpose approaches for analysis, reporting, and regulatory submission deliverables (e.g., annotated CRFs, dataset transport files, define documents, reviewer guides).
- Create frameworks for strategy, resourcing, analysis, and delivery; improve processes/technology.
- Build expertise in specialized clinical data/study considerations (e.g., PK/PD, biomarkers, labs, healthy volunteers, special populations).
- Lead programming standards/conventions; develop statistical programming infrastructure.
- Plan/assess workload and resourcing; hire/train/coach/oversee in-house and contract programmers.
- Assess software needs; manage/validate external vendor programming (e.g., CDISC implementation, analysis reporting).
- Create/validate e-submission requirements.
- Lead agency reporting deliverables (DSUR/Annual Report, IB updates); act as lead and/or QC programmer as needed.
Requirements
- BS/BA + 10+ yrs, OR Master’s + 8+ yrs, OR PhD + 6+ yrs as a statistical programmer in biopharma/CRO with advanced SAS (Base/Stat/Macro/graph); plus prior managerial/functional management experience.
- Thought leadership; broad functional process understanding; advanced relational databases/complex data systems.
- Cross-functional leadership; strong coaching, organization, time management, and communication.
- Proficiency: Microsoft Office (Word/Excel/PowerPoint).
- Working knowledge: SDTM/ADaM; integrated databases.
- Knowledge: regulatory requirements for dataset submissions (SAS and CDISC); writing/validating/documenting statistical programs; integrated programming libraries.
- Strong negotiation/influencing; excellent project management.
Compensation/Benefits (as stated)
- Annual base salary: $171,800.00–$235,000.00; target annual bonus 30% of earned base; equity long-term incentive eligibility.
- Retirement plan (company match), paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/prescription/dental/vision coverage.