Director, Biostatistics
Ipsen · Cambridge +2 more
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Role summary
Ipsen seeks a Director of Biostatistics to lead statistical strategy for neuroscience drug development programs. This senior role involves designing clinical trials, analyzing data, directing cross-functional teams, and serving as the primary statistical advisor to asset teams and regulatory authorities.
What they're looking for
- Advanced degree in biostatistics, statistics, or related field with extensive pharma experience
- Deep expertise in clinical trial design and statistical analysis methodologies
- Experience leading biostatistical teams and mentoring professionals
- Proficiency with regulatory interactions and submission preparation
- Knowledge of adaptive designs, estimands, and Bayesian statistical approaches
- Strong project management and cross-functional collaboration skills
- Experience overseeing CRO and external statistical service providers
What you'll be doing
- Serve as program-level biostatistician providing strategic statistical leadership for neuroscience assets
- Author and review clinical study protocols, statistical analysis plans, and regulatory submission documents
- Lead regulatory interactions with FDA, EMA, PMDA and other health authorities
- Evaluate clinical trial data, prepare presentations, and communicate results to stakeholders
- Oversee biostatistical deliverables quality, timelines, and CRO performance; mentor team members
Privacy & handoff
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