Director, Biostatistics

Ipsen

About The Position

The Director, Biostatistics will be working in a cross functional team, responsible for providing program and project-level statistical expertise and leadership in the development of Ipsen neuroscience assets. This position reports to the Senior Director of Biostatistics, Neuroscience. The Director of Biostatistics is a senior statistical leader serving as the primary biostatistical partner for one or more assets within Ipsen’s neuroscience development portfolio. This is a highly strategic and visible individual contributor role, providing expert statistical leadership, partnership, and innovation to drive the design, conduct, and analysis of rigorous and informative development programs. The Director will act as a trusted advisor and subject matter expert to asset teams and internal stakeholders, ensuring robust methodology, scientific excellence, and compliance. The role also plays a key part in continuous improvement of statistical processes, standards, and vendor collaboration, enhancing quality and efficiency across Biometry.

Requirements

10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS
Advanced knowledge and practical experience of widely used clinical study designs as well as complex study designs.
Hands-on familiarity with common and advanced statistical methodology including methods adopted in adaptive design.
Expertise in applying, analysing, reporting, and interpreting both descriptive and inferential statistics.
Strong knowledge of statistical computing and programming principles, including SAS and R, with the ability to leverage emerging analytical and visualization tools to support efficient and reproducible analyses.
Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
Excellent communication skills, both written and verbal, with the ability to convey complex statistical concepts clearly across functional areas.
Strong attention to detail.
Proven ability to collaborate effectively in global, cross-functional, and culturally diverse teams; strong interpersonal and relationship-building skills.
Demonstrated initiative, flexibility, and independent problem-solving skills with a proactive, positive approach.
Strong project and time management skills.
Deep understanding of statistical methodologies, clinical study designs, and the drug development process.
Ability to see the big picture while maintaining attention to detail.
Ability to manage multiple complex projects and assess resource needs.
MS in statistics or biostatistics is required.
Fluent in English, with excellent verbal and written

Nice To Haves

Neuroscience drug development experience is highly desired.
Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.
PhD in statistics or biostatistics is strongly preferred.

Responsibilities

Work as program-level lead biostatistician in cross-functional team(s). Responsible for providing strategic support to Ipsen asset team(s), as well as authoring and reviewing key study documents such as study protocol, statistical analysis plan, dataset specifications, clinical study report, publications, and regulatory submission documents.
Provide strategic leadership and direction within neuroscience programs, leveraging deep expertise to influence product and/or business strategy.
Lead and coordinate the planning and execution of biostatistics deliverables, ensuring quality and adherence to timeline, by collaborating with internal and CRO team members.
Lead or support interactions with global health authorities (FDA, EMA, PMDA and other agencies), including briefing packages, meeting preparation, response strategy, and statistical defense of development decisions.
Make decisions guided by functional, divisional, and enterprise-level priorities, with a direct impact on business outcomes.
Drive adoption of innovative statistical methodologies and trial designs, including adaptive designs, estimand frameworks, Bayesian approaches, and other emerging methods as appropriate.
Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, and statistical analysis interpretation, reporting, and presentation of clinical study results.
Evaluate and interpret clinical trial data, prepare slides, and present results to internal and external stakeholders.
Provide strategic oversight of CROs and statistical service providers, ensuring methodological rigor, operational excellence, quality, and regulatory compliance of all statistical deliverables.
Support the preparation and validation of statistical analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis.
Assess resource requirements, proactively identify portfolio risks, and develop mitigation strategies to ensure achievement of key development milestones.
Play a critical role in shaping team development through ongoing training, mentorship and career development opportunities, and contribute to departmental strategy.
Lead or contribute to high-visibility, cross-functional initiatives of strategic importance, including long term digital and data strategy, refinement of external sourcing, and optimization of internal processes.