Senior Statistician II

Biostatistics Contractor – Phase 3 Support

• Location: Remote / Hybrid
• Engagement: Contract (Full-time preferred)
• Start: ASAP

Role Summary

• Support active Phase 3 clinical development programs
• Work closely with the internal statistics lead
• Provide high-quality technical execution, CRO deliverable review, background research, and analysis support
• Execution-focused role; not a Phase 3 statistical lead position

Key Responsibilities

• Support Phase 3 statistical activities under the direction of the statistics lead
• Review CRO deliverables (SAP sections, shells, outputs) for accuracy, assumptions, and alignment
• Perform targeted literature reviews and summarize precedent to support analysis discussions
• Assist with mock analyses, sensitivity analyses, or background analyses as needed
• Support preparation and review of regulatory documents and responses
• Track and resolve CRO comments and follow-ups
• Ensure aligned analysis strategies are implemented consistently

Required Qualifications

• 5–6+ years of biostatistics experience
• Prior involvement in at least one Phase 3 clinical trial
• Experience supporting SAP development and regulatory-facing deliverables
• Solid understanding of Asthma/COPD endpoints.
• Understanding of statistical deliverables like SAP, analyses, DSMB, ISS etc.
• Working knowledge of SAS and/or R
• Experience working with CROs in a sponsor-support role

Key Skills & Attributes

• Strong attention to detail and execution quality
• Ability to follow agreed analysis strategies precisely
• Evidence-based approach to problem solving
• Clear, professional written and good verbal communication
• Comfortable asking clarifying questions and escalating appropriately