The Lotus Group LLC
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Overview
Our client, a well-established biotechnology company, is seeking an experienced Biostatistics professional to support clinical development programs across multiple stages. This role partners closely with Clinical Development, Regulatory, Data Management, and Programming to shape trial design, guide analyses, and support regulatory deliverables.
Level will be determined based on experience and scope.
What You’ll Do
- Provide statistical leadership for clinical trial design and analysis
- Serve as the biostatistics partner on cross-functional development teams
- Author and review statistical sections of protocols and analysis plans
- Collaborate with programming teams on analysis datasets and outputs
- Support clinical study reports and regulatory-facing documents
- Manage CRO statistical and programming activities
- Contribute to interpretation of trial results and scientific communications
What We’re Looking For
- Ph.D. in Biostatistics, Statistics, or a related quantitative field
- 3+ years of biostatistics experience in pharma or biotech clinical development
- Strong expertise in clinical trial statistics
- Proficiency in SAS; experience with R is a plus
- Ability to communicate effectively with cross-functional stakeholders
Nice to Have
- Experience supporting Phase 2/3 or late-stage programs
- Prior experience as lead statistician on clinical studies
- Familiarity with CDISC standards and regulatory guidelines
Why Consider This Role?
- Opportunity to influence high-impact clinical programs
- Competitive compensation and benefits