Associate Director Statistical Programming - Pharmacometrics
Regeneron
June 27, 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 and QC for analysis datasets and TFLs across projects using standard data models/tools.
- Provide project leadership and resource planning/coordinating deliverables across projects; manage and maintain programming specifications.
- Lead integration of data across studies for Exposure-response, PopPK, PopPKPD, and 2.7.2.
- Provide programming support for PMX deliverables (HAR requests, data-driven analyses, publications, conference materials).
- Plan and lead creation/validation of electronic submission requirements (annotated CRFs, data export files, define documents).
- Work in multidisciplinary teams to support analysis and reporting through regulatory approval, product launch, and annual reports.
- Independently design/test program logic; code programs; develop program documentation and prepare programs.
- Support validation planning/study requirement evaluation; perform project management administrative functions (resource/milestone compilation, requirement change identification/communication, resource strategy with department head).
- Provide guidance implementing/executing programming and project standards.
- Requires 4 days onsite presence (Tarrytown, NY or Warren, NJ).
Qualifications:
- Master’s in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related.
- 10+ years programming experience (preferred clinical trial data in biotech/pharma/health industry).
- Experience in project and people management; expertise in one or more therapeutic areas preferred.
- SAS Certification desirable in statistics/computer science.
Required/Preferred Skills:
- Expert SAS (Base, Stat, Macro, graph) in clinical data environment.
- CDISC standardization and creation of current CDISC data standards.
- Biostatistics/pharmaceutical clinical development knowledge (safety/efficacy); ability to handle/perform PK, immunogenicity, exposure-response analyses.
- Relational database/reporting system understanding; experience with Windows SAS/SAS Studio, MS Excel, R and/or Python.
- Mentoring of junior staff; collaborative leadership.
- Knowledge of AI use cases in statistical programming/data science.
Application:
- Apply now to be considered for the opportunity.
Responsibilities:
- Provide timely programming support to study teams per project strategies; lead programming and QC for analysis datasets and TFLs across projects using standard data models/tools.
- Provide project leadership and resource planning/coordinating deliverables across projects; manage and maintain programming specifications.
- Lead integration of data across studies for Exposure-response, PopPK, PopPKPD, and 2.7.2.
- Provide programming support for PMX deliverables (HAR requests, data-driven analyses, publications, conference materials).
- Plan and lead creation/validation of electronic submission requirements (annotated CRFs, data export files, define documents).
- Work in multidisciplinary teams to support analysis and reporting through regulatory approval, product launch, and annual reports.
- Independently design/test program logic; code programs; develop program documentation and prepare programs.
- Support validation planning/study requirement evaluation; perform project management administrative functions (resource/milestone compilation, requirement change identification/communication, resource strategy with department head).
- Provide guidance implementing/executing programming and project standards.
- Requires 4 days onsite presence (Tarrytown, NY or Warren, NJ).
Qualifications:
- Master’s in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related.
- 10+ years programming experience (preferred clinical trial data in biotech/pharma/health industry).
- Experience in project and people management; expertise in one or more therapeutic areas preferred.
- SAS Certification desirable in statistics/computer science.
Required/Preferred Skills:
- Expert SAS (Base, Stat, Macro, graph) in clinical data environment.
- CDISC standardization and creation of current CDISC data standards.
- Biostatistics/pharmaceutical clinical development knowledge (safety/efficacy); ability to handle/perform PK, immunogenicity, exposure-response analyses.
- Relational database/reporting system understanding; experience with Windows SAS/SAS Studio, MS Excel, R and/or Python.
- Mentoring of junior staff; collaborative leadership.
- Knowledge of AI use cases in statistical programming/data science.
Application:
- Apply now to be considered for the opportunity.