Director, Biostatistics

Title: Director, Biostatistics

Company: Ipsen Biopharmaceuticals Inc.

About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description

Director, Biostatistics

WHAT - Summary & Purpose of 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.

WHAT - Main Responsibilities & Technical Competencies

• 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.

HOW - Behavioural Competencies Required

Competency Competency Behavioural Markers Explanation of Choice

Ensures Accountability

• Ensures sin