Senior Director, Biostatistics Rare Disease

## Sr.

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Director, Biostats-Rare DiseaseApplylocations: Paris: Cambridge One Main: Londontime type: Full timeposted on: Posted Todayjob requisition id: R-21901
Title:
Sr.

Director, Biostats-Rare Disease
Company:
Ipsen Innovation (SAS)
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 societyFor more information, visit us at
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Job Description:
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.

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* 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.<