Associate Principal Scientist, Statistical Programming β Rahway, NJ
Responsibilities:
- Lead statistical programming for multiple/complex late-stage clinical trial programs.
- Develop and execute statistical analysis/reporting deliverables (safety/efficacy datasets, tables, listings, figures) across trials through worldwide regulatory submissions and post-marketing support.
- Collaborate with biostatisticians, project leads, data managers, and stakeholders to deliver high-quality outputs on time.
- Serve as statistical programming point of contact and knowledge holder across the product lifecycle.
- Develop SAS and R programs to create/validate ADaM datasets and TFLs for clinical study reports and regulatory submissions.
- Ensure deliverable quality and process compliance; develop/maintain SAS macro libraries.
- Manage project plans including resource forecasting; coordinate a global programming team (including outsource staff).
- Participate in departmental strategic initiatives (e.g., statistical computing platform evaluation/development).
Qualifications:
- Bachelorβs (or US equivalent) + 9+ years SAS programming in clinical trials OR Masterβs (or US equivalent) + 7+ years.
- Experience leading large/complex Phase 2/3 statistical programming projects; coordinating programming teams.
- Leadership-level experience with US/worldwide regulatory application submissions (including electronic submission deliverables).
Skills/Requirements:
- Strong SAS (data steps, procedures, SAS/MACRO, SAS/GRAPH) and systems/database expertise; strong statistical analysis and clinical data management familiarity.
- CDISC and ADaM expertise.
- Strong project management; mentor; stakeholder engagement; communication/negotiation.
Salary/Benefits:
- Salary range: $144,373.00β$224,100.00. 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:
- Current Employees apply HERE; Current Contingent Workers apply HERE.