Associate Director Statistical Programming - Pharmacometrics
Regeneron
August 08, 2026
On-site
Tarrytown, NY
Clinical Research and Development
Responsibilities:
- Provide timely programming support to study teams according to project strategies; lead programming support for processing/analyzing/storing clinical study data per Statistical Analysis Plan, clinical pharmacology reporting requirements, and programming specifications.
- Provide project leadership; plan and coordinate deliverables within/across projects, including resource planning, milestones, and communicating requirement changes impacting key deliverables.
- Work independently to design and test program logic; code programs; develop program documentation and program preparation.
- Lead programming and QC of analysis datasets and TFLs across projects/standard tools using internal standards and guidelines; create and maintain analysis dataset programming specifications.
- Lead integration of data for Exposure-response, PopPK, PopPKPD (including 2.7.2).
- Provide PMX deliverable support for HAR requests, data-driven analyses, publications, and conferences.
- Plan and lead creation and validation of electronic submission requirements (annotated CRF, data export files, define documents).
- Work with multidisciplinary teams to support analysis/reporting through regulatory approval, product launch, and annual reports.
Qualifications/Requirements:
- On-site: 4 days onsite based out of Tarrytown, NY or Warren, NJ.
- Master’s in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
- 10+ years programming experience processing clinical trial data in biotech/pharma/health industry; project and people management experience; expertise in one or more therapeutic areas preferred.
- SAS certification desirable (statistics/computer science).
Skills (required/preferred):
- Expert SAS (Base, Stat, Macro, graph) in clinical data environments.
- Relational database/reporting system understanding; implement standardization methodology and CDISC data standards.
- Strong biostatistics and clinical development knowledge (safety/efficacy); ability to handle/perform PK, immunogenicity, and exposure-response analyses.
- Proficiency with Windows SAS, SAS Studio, MS Excel; R and/or Python.
- Ability to mentor junior staff.
- Knowledge of AI use cases in statistical programming/data sciences.
Application:
- Apply now.
- Provide timely programming support to study teams according to project strategies; lead programming support for processing/analyzing/storing clinical study data per Statistical Analysis Plan, clinical pharmacology reporting requirements, and programming specifications.
- Provide project leadership; plan and coordinate deliverables within/across projects, including resource planning, milestones, and communicating requirement changes impacting key deliverables.
- Work independently to design and test program logic; code programs; develop program documentation and program preparation.
- Lead programming and QC of analysis datasets and TFLs across projects/standard tools using internal standards and guidelines; create and maintain analysis dataset programming specifications.
- Lead integration of data for Exposure-response, PopPK, PopPKPD (including 2.7.2).
- Provide PMX deliverable support for HAR requests, data-driven analyses, publications, and conferences.
- Plan and lead creation and validation of electronic submission requirements (annotated CRF, data export files, define documents).
- Work with multidisciplinary teams to support analysis/reporting through regulatory approval, product launch, and annual reports.
Qualifications/Requirements:
- On-site: 4 days onsite based out of Tarrytown, NY or Warren, NJ.
- Master’s in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
- 10+ years programming experience processing clinical trial data in biotech/pharma/health industry; project and people management experience; expertise in one or more therapeutic areas preferred.
- SAS certification desirable (statistics/computer science).
Skills (required/preferred):
- Expert SAS (Base, Stat, Macro, graph) in clinical data environments.
- Relational database/reporting system understanding; implement standardization methodology and CDISC data standards.
- Strong biostatistics and clinical development knowledge (safety/efficacy); ability to handle/perform PK, immunogenicity, and exposure-response analyses.
- Proficiency with Windows SAS, SAS Studio, MS Excel; R and/or Python.
- Ability to mentor junior staff.
- Knowledge of AI use cases in statistical programming/data sciences.
Application:
- Apply now.