Senior Director, Biostatistics Rare Diseases

Ipsen Biopharmaceuticals Inc.; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Ipsen Biopharmaceuticals Inc. in the United States seeks a Senior Director of Biostatistics for Rare Diseases to provide program-level statistical leadership across assets and mentoring for a biostatistics team.

You will collaborate with cross-functional partners, engage with regulatory authorities, ensure data integrity, and contribute to development plans and regulatory submissions, while shaping analytics strategy and advancing patient outcomes in rare diseases.

Qualifications

• Lead and mentor a team of biostatisticians.
• Provide program- and project-level statistical leadership for rare disease assets.
• Engage with regulatory agencies and academic institutions to align with standards.
• Ensure data integrity and regulatory compliance.

Responsibilities

• Lead program-level biostatistician in cross-functional teams; author study documents such as SAPs and CSRs.
• Provide strategic leadership within rare disease programs.
• Coordinate planning and execution of biostatistics deliverables with internal and CRO teams.
• Ensure accuracy, precision and robustness in planning, design and analysis of trials.
• Support regulatory documents and scientific publications; internal ad-hoc analyses.
• Mentor and develop team; contribute to departmental strategy.
• Lead cross-functional initiatives like data strategy and process optimization.

Skills

Biostatistics leadership

Statistical analysis

Regulatory submission

Job description

Senior Director, Biostatistics Rare Diseases

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

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 within the biometrics department with clinicians, regulatory affairs, medical writing, clinical operations, service/technology providers, and 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