Sr. Director, Biostats-Rare Disease

Senior Director, Biostatistics

Senior Director of Biostatistics will lead a cross‑functional team, providing program‑ and project‑level statistical expertise to develop Ipsen’s rare disease portfolio. The position reports to the Head of Biostatistics (USA) and focuses on statistical leadership, regulatory alignment, and team mentoring to ensure high‑quality, compliant clinical data and analyses.

Key Responsibilities

• Act as program-level lead biostatistician in cross‑functional teams.
• Provide strategic support and author/review key study documents – protocols, statistical analysis plans, dataset specifications, clinical study reports, publications, and regulatory submissions.
• Lead and coordinate the planning and execution of biostatistics deliverables, ensuring quality, adherence to timelines, and collaboration with internal stakeholders and CRO partners.
• Make decisions guided by functional, divisional, and enterprise priorities, directly impacting business outcomes.
• Ensure accuracy, precision, efficiency, and robustness in statistical planning, study design, analysis, interpretation, reporting, and presentation of clinical results.
• Evaluate and interpret clinical trial data, prepare presentation slides, and present results to internal and external stakeholders.
• Provide oversight and guidance to CRO partners on data collection and summarization strategies.
• Validate and quality‑control CRO statistical deliverables for accuracy and compliance.
• Support preparation and validation of statistical analyses for regulatory documents and scientific publications.
• Engage in internal ad‑hoc and exploratory analyses as needed.
• Shape team development through training, mentorship, and career development initiatives.
• Lead or contribute to high‑visibility, cross‑functional initiatives including digital and data strategy, external sourcing refinement, and process optimization.

Required Qualifications & Experience

• 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 of widely used and complex clinical study designs, including adaptive, and strong methodological expertise (missing data, multiplicity).
• Hands‑on experience with SAS programming and proficiency in R, EAST, nQuery, and JMP.
• Proficiency with CDISC standards and programming of raw datasets, SDTM, and ADaM.
• Excellent written and verbal communication skills, capable of conveying complex statistical concepts to diverse audiences.
• Strong attention to detail and rigorous quality orientation.
• Proven ability to collaborate effectively in global, cross‑functional, and culturally diverse teams.
• Proactive initiative, flexibility, independent problem‑solving aptitude, and a positive, collaborative mindset.
• Strong project and time‑management skills with experience managing multiple complex projects and assessing resource needs.
• Deep understanding of the drug development lifecycle and statistical methodology within that context.

Preferred Qualifications

• Experience in rare disease drug development.
• Regulatory submission experience with US FDA, EMA, PMDA.
• PhD in statistics or biostatistics.
• Fluency in English (written and spoken).

Behavioral Competencies

• Accountability – Owns outcomes, assures clarity of responsibilities, and follows through on commitments.
• Talent Development – Identifies career goals, provides structured coaching, and promotes high‑performance teamwork.
• Vision and Strategy – Articulates a compelling future state and directs others toward strategic objectives.
• Complexity Management – Evaluates alternative scenarios, prioritizes impactful decisions, and navigates contradictory inputs.
• Effective Communication – Articulates complex ideas transparently, uses structured messages, and employs storytelling for clarity.

EEO Statement

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons «The Real Us». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l’inclusion et de l’égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous‑même lorsque vous postulez à un poste chez nous. Si vous avez besoin d’aménagements ou d’aide pendant le processus de candidature, veuillez en informer l’équipe de recrutement. Ces informations seront traitées avec soin et n’auront aucune incidence sur le résultat de votre candidature.