Senior Director, Biostatistics Rare Disease

Title:

Company:

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:

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

mpetency

Competency Behavioural Markers

Explanation of Choice

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

This role requires strong ownership of statistical deliverables, regulatory submissions, and oversight of CROs. Accountability is essential for ensuring data integrity and compliance.

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

The role includes leading and mentoring a team of biostatisticians. Coaching and talent development are critical to building a high-performing team.

Drive Vision and Strategy (2)

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

This role requires strategic leadership in rare disease programs and influencing product strategy. Visionary thinking is essential for long-term success.

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

The role involves navigating complex data, regulatory requirements, and cross-functional collaboration. Managing complexity is key to effective decision-making.

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

Effective communication is vital for regulatory interactions, cross-functional leadership, and scientific publications.

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