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
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