Associate Principal Scientist, Statistical Programming
Merck
August 08, 2026
On-site
Rahway, NJ
Clinical Research and Development
Associate Principal Scientist, Statistical Programming – Rahway, NJ
Responsibilities
- Lead statistical programming activities for multiple/complex late-stage clinical trial development programs.
- Develop and execute statistical analysis and reporting deliverables (e.g., safety/efficacy datasets, tables, listings, figures) across trials through global regulatory submissions and post-marketing support.
- Collaborate with biostatisticians, project leads, data managers, and stakeholders to deliver high-quality work on time.
- Serve as statistical programming point of contact/knowledge holder through the product lifecycle.
- Develop SAS and R programs to create/validate ADaM datasets and TFLs for clinical study reports and regulatory submissions (FDA, EMA, etc.).
- Ensure deliverable quality and process compliance.
- Develop/maintain macro libraries (global and project-specific).
- Manage project plans including resource forecasting; coordinate global programming team (including outsource providers).
- Participate in departmental strategic initiatives (e.g., statistical computing platform evaluation/development).
Qualifications (Minimum)
- Bachelor’s degree (or US equivalent) in a relevant field + 9+ years SAS clinical trial programming, OR Master’s degree + 7+ years SAS clinical trial programming.
- Leadership experience on large/complex Phase 2/3 programming projects.
- Leadership-level drug regulatory submission experience (electronic submission deliverables).
- CDISC and ADaM expertise.
- SAS expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems/database knowledge.
- Familiarity with statistical analysis methods and clinical data management concepts.
- Strong project management, mentoring, stakeholder engagement, communication/negotiation, change adaptability, and strategic/tactical thinking.
Compensation/Benefits (if applicable)
- Salary range: $144,373.00–$224,100.00
- Eligible for annual bonus and long-term incentive, if applicable.
- Benefits include medical/dental/vision insurance, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application
- Current employees apply HERE; current contingent workers apply HERE.
Responsibilities
- Lead statistical programming activities for multiple/complex late-stage clinical trial development programs.
- Develop and execute statistical analysis and reporting deliverables (e.g., safety/efficacy datasets, tables, listings, figures) across trials through global regulatory submissions and post-marketing support.
- Collaborate with biostatisticians, project leads, data managers, and stakeholders to deliver high-quality work on time.
- Serve as statistical programming point of contact/knowledge holder through the product lifecycle.
- Develop SAS and R programs to create/validate ADaM datasets and TFLs for clinical study reports and regulatory submissions (FDA, EMA, etc.).
- Ensure deliverable quality and process compliance.
- Develop/maintain macro libraries (global and project-specific).
- Manage project plans including resource forecasting; coordinate global programming team (including outsource providers).
- Participate in departmental strategic initiatives (e.g., statistical computing platform evaluation/development).
Qualifications (Minimum)
- Bachelor’s degree (or US equivalent) in a relevant field + 9+ years SAS clinical trial programming, OR Master’s degree + 7+ years SAS clinical trial programming.
- Leadership experience on large/complex Phase 2/3 programming projects.
- Leadership-level drug regulatory submission experience (electronic submission deliverables).
- CDISC and ADaM expertise.
- SAS expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems/database knowledge.
- Familiarity with statistical analysis methods and clinical data management concepts.
- Strong project management, mentoring, stakeholder engagement, communication/negotiation, change adaptability, and strategic/tactical thinking.
Compensation/Benefits (if applicable)
- Salary range: $144,373.00–$224,100.00
- Eligible for annual bonus and long-term incentive, if applicable.
- Benefits include medical/dental/vision insurance, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application
- Current employees apply HERE; current contingent workers apply HERE.