Senior Director, Biostatistics Rare Disease

Ipsen; Paris; Sur place; EUR 180 000 - 240 000; Plein temps

Résumé du poste

Ipsen, Paris, seeks a Senior Director, Biostatistics to provide program-level statistical leadership across rare disease assets. You will mentor a team of biostatisticians and collaborate with global partners to shape clinical development plans and regulatory submissions.

You will drive advanced analytical methods, oversee study design and analysis, ensure data integrity and regulatory compliance, and foster cross-disciplinary partnerships with clinicians, data management, and programming.

Qualifications

• 10+ years in pharma with a PhD or 12+ years with an MS
• 5+ years in a leadership role
• Expertise in adaptive designs and endpoints
• Proven ability to collaborate across global teams

Responsabilités

• Provide strategic leadership in rare disease programs and author key study documents
• Lead program-level biostatistics deliverables and study design
• Collaborate with CROs and internal teams for regulatory readiness and data integrity
• Mentor and develop biostatistics talent and contribute to departmental strategy
• Drive cross-functional initiatives and data strategy

Connaissances

Leadership

Cross-functional

Biostatistics methods

Regulatory submissions

Formation

MS in statistics/biostatistics

PhD in statistics/biostatistics

Outils

SAS

R

EAST

nQuery

JMP

CDISC

Description du poste

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, 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

Drive Vision and Strategy (2)

• Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action

Manage Complexity (6)

• 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

Communicates Effectively (22)

• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non-verbally) and able to relate to other points of view
• Communicates transparently, tells it how it is while keeping the communication respectful
• Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes
• Demonstrates gravitas

HOW - Knowledge & Experience

Knowledge & Experience (essential)

• 10+ years of pharmaceutical industry experience with a PhD, or 12+ years with an MS; at least 5 years in a leadership role.
• Advanced knowledge and practical experience of widely used clinical study designs as well as complex study designs.
• Hands‑on familiarity with common and advanced statistical methodology including methods adopted in adaptive design.
• Expertise in applying, analyzing, reporting, and interpreting both descriptive and inferential statistics.
• Strong knowledge of SAS programming concepts and techniques in the pharmaceutical, with the ability to proactively address strategic limitations; proficiency in tools such as SAS, R, EAST, nQuery, and JMP.
• Hands‑on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets.
• Excellent communication skills, both written and verbal, with the ability 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.

Knowledge & Experience (preferred)

• Rare disease drug development experience is highly desired.
• Regulatory submission (US FDA, EMA, PMDA) experience is highly desired.

Education / Certifications (essential)

• MS in statistics or biostatistics is required.

Education / Certifications (preferred)

• PhD in statistics or biostatistics is strongly preferred.

Language(s) (essential)

• Fluent in English, with excellent verbal and written