Associate Director Statistical Programming - Pharmacometrics
Regeneron
August 30, 2026
On-site
Tarrytown, NY
Clinical Research and Development
Associate Director, Pharmacometrics Programming
Responsibilities:
- Provide timely programming support to study teams per project strategies; lead programming activities and resource planning for deliverables across projects.
- Lead programming support for processing/analyzing/storing clinical study data per Statistical Analysis Plan, clinical pharmacology report requirements, and programming specifications using internal standards.
- Design/test program logic; code programs; develop program documentation and program preparation.
- Guide implementation/execution of programming and project standards; evaluate/develop study requirements and validation plans.
- Manage administrative project needs: compile resource requirements/milestones; identify/communicate requirement changes impacting key deliverables; develop resource strategies with department head.
- Lead programming/QC of analysis datasets and TFLs (multi-project); create/manage analysis dataset programming specifications.
- Lead cross-study data integration for Exposure-response, PopPK/PopPKPD and 2.7.2.
- Support PMX deliverables for HAR requests, data-driven analysis, publications, and conferences.
- Plan/lead creation and validation of electronic submission requirements (annotated CRF, data export files, define documents).
- Support multidisciplinary teams with clinical trial analysis/reporting through regulatory approval, product launch, and annual reports.
Requirements/Qualifications:
- Master’s in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
- 10+ years clinical trial programming experience (biotech/pharma/health preferred); project and people management experience; therapeutic area expertise preferred.
- SAS Certification desirable.
Skills:
- Expert SAS (Base/Stat/Macro/graph) in clinical data environments.
- Understanding of relational databases/reporting systems; standardization methodology and CDISC data standards.
- Biostatistics/pharmaceutical clinical development knowledge (safety/efficacy); PK/immunogenicity/exposure-response analysis.
- SAS Studio, MS-Excel, R and/or Python; AI use cases in statistical programming/data science.
- Mentor junior staff.
Location:
- 4 days onsite (Tarrytown, NY or Warren, NJ).
Application:
- Apply now.
Responsibilities:
- Provide timely programming support to study teams per project strategies; lead programming activities and resource planning for deliverables across projects.
- Lead programming support for processing/analyzing/storing clinical study data per Statistical Analysis Plan, clinical pharmacology report requirements, and programming specifications using internal standards.
- Design/test program logic; code programs; develop program documentation and program preparation.
- Guide implementation/execution of programming and project standards; evaluate/develop study requirements and validation plans.
- Manage administrative project needs: compile resource requirements/milestones; identify/communicate requirement changes impacting key deliverables; develop resource strategies with department head.
- Lead programming/QC of analysis datasets and TFLs (multi-project); create/manage analysis dataset programming specifications.
- Lead cross-study data integration for Exposure-response, PopPK/PopPKPD and 2.7.2.
- Support PMX deliverables for HAR requests, data-driven analysis, publications, and conferences.
- Plan/lead creation and validation of electronic submission requirements (annotated CRF, data export files, define documents).
- Support multidisciplinary teams with clinical trial analysis/reporting through regulatory approval, product launch, and annual reports.
Requirements/Qualifications:
- Master’s in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
- 10+ years clinical trial programming experience (biotech/pharma/health preferred); project and people management experience; therapeutic area expertise preferred.
- SAS Certification desirable.
Skills:
- Expert SAS (Base/Stat/Macro/graph) in clinical data environments.
- Understanding of relational databases/reporting systems; standardization methodology and CDISC data standards.
- Biostatistics/pharmaceutical clinical development knowledge (safety/efficacy); PK/immunogenicity/exposure-response analysis.
- SAS Studio, MS-Excel, R and/or Python; AI use cases in statistical programming/data science.
- Mentor junior staff.
Location:
- 4 days onsite (Tarrytown, NY or Warren, NJ).
Application:
- Apply now.