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 single accountable referents per task/project/outcome (independent of organizational context or multi-team projects) • Builds and anchors an environment where people have the skills and habits to ask for clarification when accountabilities are unclear • Consults/seeks relevant stakeholder views/expertise and coaches/ensures decisions are made by consent vs. consensus • Takes personal accountability for decisions, actions, successes and failures, and fosters the same for others • Follows through on commitment and makes sure others do the same. This role requires strong ownership of statistical deliverables, regulatory submissions, and oversight of CROs. Accountability is essential for ensuring data integrity and compliance. Develops/Coaches Talent • Able to identify and align career goals, and blend organizational objectives into a cohesive development plan for self and team • Able to coach • Provides structured, actionable, regular and directional feedback and acts as a coach to empower people to own their own growth/development • Prepares their own succession plans • Displays a radically human-centered mindset; puts people first; focuses on doing good • Demonstrates ability to build team effectiveness. The role includes leading and mentoring a team of biostatisticians. Coaching and talent development are critical to building a high-performing team. Drive Vision and Strategy • Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action This role requires strategic leadership in neuroscience programs and influencing product strategy. Visionary thinking is essential for long-term success. Manage Complexity • Identifies contradictory information/demands/inputs to effectively solve problems • Develops and evaluates alternative scenario and solutions • Able to identify what truly matters and ruthlessly focus/ prioritize on making decisions with real impact The role involves navigating complex data, regul