Director, Biostatistics

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

Job summary

Ipsen Biopharmaceuticals Inc. is seeking a Director, Biostatistics to lead statistical strategy within cross-functional neuroscience programs, design and analyze studies, and act as the primary biostatistical partner for assets.

This senior, individual contributor role requires expert methodology, regulatory acumen, and collaboration with asset teams and CROs. You will influence study design, support FDA/EMA interactions, advance innovative methods, mentor biostatisticians, and help shape

Qualifications

• Minimum 10+ years in pharma/biotech biostatistics; advanced regulatory submissions experience.
• Strong knowledge of clinical trial design, adaptive methods, and estimands.
• Proven ability to lead statistical strategies in cross-functional teams.

Responsibilities

• Provide program-level statistical leadership for neuroscience assets.
• Lead preparation of study protocols, SAPs, datasets, CSR, and regulatory submissions.
• Collaborate with CROs and internal teams to ensure high-quality deliverables.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory submissions

SAS and R

Adaptive design knowledge

Data interpretation

Education

MS in statistics or biostatistics

PhD in statistics or biostatistics (preferred)

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Title:Director, Biostatistics 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

WHAT - Summary & Purpose of the Position

The 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 neuroscience assets. This position reports to the Senior Director of Biostatistics, Neuroscience. The Director of Biostatistics is a senior statistical leader serving as the primary biostatistical partner for one or more assets within Ipsen’s neuroscience development portfolio. This is a highly strategic and visible individual contributor role, providing expert statistical leadership, partnership, and innovation to drive the design, conduct, and analysis of rigorous and informative development programs. The Director will act as a trusted advisor and subject matter expert to asset teams and internal stakeholders, ensuring robust methodology, scientific excellence, and compliance. The role also plays a key part in continuous improvement of statistical processes, standards, and vendor collaboration, enhancing quality and efficiency across Biometry.

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 neuroscience 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.
• Lead or support interactions with global health authorities (FDA, EMA, PMDA and other agencies), including briefing packages, meeting preparation, response strategy, and statistical defense of development decisions.
• Make decisions guided by functional, divisional, and enterprise-level priorities, with a direct impact on business outcomes.
• Drive adoption of innovative statistical methodologies and trial designs, including adaptive designs, estimand frameworks, Bayesian approaches, and other emerging methods as appropriate.
• 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 strategic oversight of CROs and statistical service providers, ensuring methodological rigor, operational excellence, quality, and regulatory compliance of all 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.
• Assess resource requirements, proactively identify portfolio risks, and develop mitigation strategies to ensure achievement of key development milestones.
• 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

Competency Competency Behavioural Markers Explanation of Choice

Ensures Accountability Ensures single accountable referents per task/project/outcome 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 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 Paints a compelling picture of the vision (future status quo) and strategy that motivates others to action This role requires strategic leadership in neuroscience programs and influencing product strategy. Visionary thinking is essential for long-term success.

Manage Complexity 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 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
• 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, analysing, reporting, and interpreting both descriptive and inferential statistics.
• Strong knowledge of statistical computing and programming principles, including SAS and R, with the ability to leverage emerging analytical and visualization tools to support efficient and reproducible analyses.
• 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)

• Neuroscience 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

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace The Real Us. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s 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. At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life-changing projects that create positive impact for patients and society.

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