Overview
As Director, Biostatistics you will provide strategic, program-level statistical leadership within Ipsen’s neuroscience portfolio. You will partner with asset teams, shape study designs and analyses, and drive robust statistical decisions across regulatory submissions. You’ll lead cross-functional collaborations, oversee CROs, and advance innovative methods to improve efficiency and study quality. This role offers high visibility in shaping neuroscience development and data strategy within a global, mission-driven company.
Responsibilities
- Act as program-level lead biostatistician for neuroscience assets and author/review key study documents (protocols, SAPs, datasets, CSRs, publications, regulatory submissions)
- Provide strategic direction to influence product and business strategy within neuroscience programs
- Coordinate biostatistics deliverables across internal and CRO teams to ensure quality and timely execution
- Engage with global regulatory authorities (FDA, EMA, PMDA) including briefing packages and statistical defense of decisions
- Make priority-driven decisions with clear link to business outcomes
- Promote adoption of innovative designs (adaptive designs, estimand frameworks, Bayesian methods)
- Ensure rigorous statistical planning, analysis, interpretation, and presentation of results
- Oversee CROs and statistical service providers for methodological rigor and regulatory compliance
- Support regulatory analyses and scientific publications; perform internal ad-hoc analyses
- Assess resources, identify portfolio risks, and develop mitigation plans
- Contribute to department strategy and mentor junior statisticians
- Lead or contribute to high-visibility cross-functional initiatives (digital/data strategy, external sourcing)
Key requirements
- 10+ years in pharma with PhD or 12+ years with MS
- Advanced knowledge of clinical study designs and complex designs
- Hands-on experience with adaptive designs and modern statistical methodologies
- Expertise in descriptive and inferential statistics
- Strong SAS and R skills; ability to leverage modern tools for reproducible analyses
- Experience with CDISC standards, SDTM/ADaM datasets
- Excellent written and spoken communication; ability to convey complex statistics across functions
- High attention to detail and strong project management
- Proven collaboration in global, cross-functional teams; proactive problem-solving
- Ability to see big picture while managing multiple complex projects
- Regulatory submission experience (preferred)
- Neuroscience drug development experience (preferred)
- Regulatory interactions experience (preferred)
- cross-functional collaboration
- communication and influence
- mentorship and people development
- SAS
- R
- CDISC (SDTM/ADaM)
Director, Biostatistics in London employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer that prioritises a human-centric workplace culture, fostering collaboration and excellence. With a commitment to employee growth, Ipsen offers opportunities for continuous improvement and innovation in the biopharmaceutical field, particularly in vibrant locations like Paris and London. Employees are empowered to thrive, making a meaningful impact on patients and society while enjoying a supportive environment that values diverse perspectives.
