Senior Director, Biostatistics Rare Disease

WHAT - Summary & Purpose Of The Position

The Senior 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 rare disease assets. This position reports to the Head of Biostatistics, based in the USA.

The Senior Director will lead and mentor a team of biostatisticians, fostering a collaborative and innovative environment. This role is pivotal in advancing Ipsen's mission to improve patient outcomes through innovative treatments. The Senior Director will also engage with external stakeholders, including regulatory agencies and academic institutions, to ensure alignment with industry standards and scientific advancements. Ensuring data integrity and compliance with regulatory standards is a critical aspect of this role.

The Senior Director will participate in the evaluation of prospective assets as part of the due diligence process, including initial assessments, pre-diligence, and full/confirmatory diligence. He/she will collaborate with other R&D functions in development of clinical development plans to inform the modelling of potential costs and revenue.

The Senior Director is expected to have an in-depth understanding of advanced statistical methods, including innovative trial designs and endpoints, missing data, and multiplicity handling. She/he will have a thorough understanding and capability to implement state-of-the-art innovative statistical methodology for the design, conduct, and evaluation of clinical trials. In addition, she/he will have the capacity to understand relevant multi-disciplinary knowledge and interact effectively with within the biometrics department with clinicians, regulatory affairs, medical writing, clinical operations, service/technology providers, as well data management and statistical programming.

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 rare disease 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.
• Make decisions guided by functional, divisional, and enterprise-level priorities, with a direct impact on business outcomes.
• 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 oversight and guidance to ensure CRO partner understands the nature of the clinical data being collected and the approaches to summarizing the information. Validate and QC CRO’s work to ensure the quality and accuracy of the 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.
• 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

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Ensures Accountability (26)

• 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

Develops/Coaches Talent (15)

• 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, action