Associate Principal Scientist, Statistical Programming
Merck
August 29, 2026
On-site
Rahway, NJ
Clinical Research and Development
Associate Principal Scientist, Statistical Programming – Rahway, NJ
Responsibilities:
- Lead statistical programming for multiple/complex late-stage clinical trial development programs.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy datasets, tables, listings, figures) for clinical trials through worldwide regulatory submissions and post-marketing support.
- Collaborate with biostatisticians, project leads, data managers, and stakeholders to ensure efficient delivery of high-quality outputs.
- Serve as statistical programming point of contact/knowledge holder across the product lifecycle.
- Develop SAS and R programs to create/validate ADaM datasets and TFL summaries for clinical study reports and regulatory submissions (FDA, EMA, etc.).
- Ensure deliverable quality and process compliance.
- Develop/maintain global and project-specific macro libraries.
- Maintain/manage project plans including resource forecasting.
- Coordinate a global programming team, including outsource provider staff.
- Contribute to departmental strategic initiatives (e.g., new statistical computing platform evaluation/development).
Education/Minimum Requirements:
- Bachelor’s (or US equivalent) in CS/Statistics/Applied Math/Life Sciences/Engineering/Pharma Sci or related + 9+ years SAS clinical trial programming; OR Master’s + 7+ years SAS clinical trial programming.
- Lead Phase 2/3 statistical programming projects; coordinate programming teams.
- Leadership-level experience with US/worldwide drug regulatory submissions, including electronic submission deliverables.
- Expertise in CDISC and ADaM; SAS programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) and systems/database expertise; familiarity with statistical analysis methods and clinical data management.
- Strong project management, mentoring, stakeholder engagement, communication/negotiation, and ability to manage change; ability to comprehend statistical analysis plans and develop complex algorithms.
Benefits:
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application instructions:
- Current Employees apply HERE; Current Contingent Workers apply HERE.
Responsibilities:
- Lead statistical programming for multiple/complex late-stage clinical trial development programs.
- Develop and execute statistical analysis and reporting deliverables (safety/efficacy datasets, tables, listings, figures) for clinical trials through worldwide regulatory submissions and post-marketing support.
- Collaborate with biostatisticians, project leads, data managers, and stakeholders to ensure efficient delivery of high-quality outputs.
- Serve as statistical programming point of contact/knowledge holder across the product lifecycle.
- Develop SAS and R programs to create/validate ADaM datasets and TFL summaries for clinical study reports and regulatory submissions (FDA, EMA, etc.).
- Ensure deliverable quality and process compliance.
- Develop/maintain global and project-specific macro libraries.
- Maintain/manage project plans including resource forecasting.
- Coordinate a global programming team, including outsource provider staff.
- Contribute to departmental strategic initiatives (e.g., new statistical computing platform evaluation/development).
Education/Minimum Requirements:
- Bachelor’s (or US equivalent) in CS/Statistics/Applied Math/Life Sciences/Engineering/Pharma Sci or related + 9+ years SAS clinical trial programming; OR Master’s + 7+ years SAS clinical trial programming.
- Lead Phase 2/3 statistical programming projects; coordinate programming teams.
- Leadership-level experience with US/worldwide drug regulatory submissions, including electronic submission deliverables.
- Expertise in CDISC and ADaM; SAS programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) and systems/database expertise; familiarity with statistical analysis methods and clinical data management.
- Strong project management, mentoring, stakeholder engagement, communication/negotiation, and ability to manage change; ability to comprehend statistical analysis plans and develop complex algorithms.
Benefits:
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application instructions:
- Current Employees apply HERE; Current Contingent Workers apply HERE.