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About the Role

The Director, Biostatistics will provide program and project-level statistical expertise and leadership in the development of Ipsen neuroscience assets. This senior individual contributor role serves as the primary biostatistical partner for one or more assets, driving the design, conduct, and analysis of development programs. The role involves acting as a trusted advisor, ensuring robust methodology, scientific excellence, and compliance, while also contributing to the continuous improvement of statistical processes and vendor collaboration.

Responsibilities

Serve as program-level lead biostatistician in cross-functional teams, providing strategic support and authoring/reviewing key study documents (protocol, SAP, CSR, publications, regulatory submissions).
Provide strategic leadership within neuroscience programs, influencing product and/or business strategy.
Lead and coordinate biostatistics deliverables, ensuring quality and adherence to timelines with internal and CRO team members.
Lead or support interactions with global health authorities (FDA, EMA, PMDA), including briefing packages, meeting preparation, response strategy, and statistical defense.
Make decisions guided by functional, divisional, and enterprise-level priorities impacting business outcomes.
Drive adoption of innovative statistical methodologies and trial designs (e.g., adaptive designs, estimand frameworks, Bayesian approaches).
Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, analysis interpretation, and reporting.
Evaluate and interpret clinical trial data, prepare presentations, and present results to stakeholders.
Provide strategic oversight of CROs and statistical service providers, ensuring methodological rigor, operational excellence, quality, and regulatory compliance.
Support the preparation and validation of statistical analyses for regulatory documents and scientific articles, including internal ad-hoc and exploratory analyses.
Assess resource requirements, identify portfolio risks, and develop mitigation strategies.
Shape team development through training, mentorship, and career development, contributing to departmental strategy.
Lead or contribute to high-visibility, cross-functional initiatives (e.g., digital and data strategy, external sourcing, process optimization).

Requirements

10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS.
Advanced knowledge and practical experience of common and complex clinical study designs.
Hands-on familiarity with common and advanced statistical methodology, including adaptive design methods.
Expertise in applying, analyzing, reporting, and interpreting descriptive and inferential statistics.
Strong knowledge of statistical computing and programming principles (SAS, R), with ability to leverage emerging analytical and visualization tools.
Hands-on experience with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
Excellent communication skills (written and verbal) to convey complex statistical concepts clearly across functional areas.
Strong attention to detail.
Proven ability to collaborate effectively in global, cross-functional, and culturally diverse teams.
Strong interpersonal and relationship-building skills.
Demonstrated initiative, flexibility, and independent problem-solving skills with a proactive, positive approach.
Strong project and time management skills.
Deep understanding of statistical methodologies, clinical study designs, and the drug development process.
Ability to see the big picture while maintaining attention to detail.
Ability to manage multiple complex projects and assess resource needs.
Neuroscience drug development experience is highly desired.
Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.

Skills

Statistical expertise
Leadership
SAS
R
CDISC standards
SDTM
ADaM
Project management
Time management
Problem-solving
Collaboration
Communication

Location

US
France
UK

Work Type

Full-time

Experience Level

Director
10+ years with PhD
12+ years with MS

Education Level

MS in statistics or biostatistics required
PhD in statistics or biostatistics strongly preferred

About the Company

Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in 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.
Tackles areas of high unmet medical need through research and innovation.
Passionate teams in over 40 countries bring medicines to patients in 88 countries.
Builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence, and impact.
Empowers individuals to be their true selves, grow, and thrive.
Committed to sustainable growth, creating real impact on patients and society.

Equal Opportunity

Committed to creating a workplace where everyone feels heard, valued, and supported.
Embraces diversity and values different perspectives and experiences.
Strives to include diverse ways of thinking to make thoughtful decisions and discover innovative solutions.
Wants to help employees perform at their best and offers adjustments or support during the application process.
Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination.
Recruits, employs, trains, compensates, and promotes without regard to race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.