Director, Biostatistics

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Job Title:

Director Biostatistics

Division / Function:

R&D / Biostatistics / Clinical Science / Biometrics

Location:

Paris FR - London UK - Cambridge US

WHAT - Summary & Purpose of the Position

The Director of Biostatistics will be working in a cross-functional team responsible for providing project-level statistical expertise and leadership in the development of Ipsen Oncology Disease assets including indications in Hematology and Solid Tumor. This position reports to the Senior Director of Oncology Biostatistics based in the USA.

The Director will lead and mentor a team of biostatisticians fostering a collaborative and innovative environment. This role is pivotal in advancing Ipsens mission to improve patient outcomes through innovative oncology treatments. The 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.

WHAT - Main Responsibilities & Technical Competencies

• Work as project-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.
• Serve as a key contributor in project planning. Work collaboratively with internal and CRO team members to coordinate the planning and execution of biostatistics deliverables with quality and within timeline.
• 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 CROs work to ensure the quality and accuracy of the statistical deliverables.
• Help prepare and validate analyses for use in regulatory documents and scientific articles. Support internal ad-hoc and exploratory analysis.
• Excellent verbal and written communication within the group and across other functional areas

Key Technical Competencies Required:

• Strong attention to detail excellent and direct communication skills strong interpersonal skills and cross-cultural understanding and sensitivity.
• Ability to see the big picture while keeping an eye on the detail.
• Ability to take initiative with a positive attitude in all circumstances.
• Flexible; independent problem solving and self-direction.
• Eager and interested in learning and growing.
• Thorough knowledge of statistics and the drug development process.

HOW - Behavioural Competencies Required

Competency

Competency Behavioural Markers

Explanation of Choice

Ensures Accountability

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 competency is important for ensuring that all tasks and projects are completed on time and to the highest standards.

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 crucial for coordinating with various stakeholders and ensuring that everyone is on the same page.

Collaborates

Collaborates and communicates without boundaries continuously removes organizational barriers

Focuses on continuous improvement; integrates and leverages key learnings showcases resourcefulness learning/experimenting at scale demonstrates strong entrepreneurial behaviors and mindset

Collaboration is essential for working effectively with different teams and ensuring smooth execution of clinical studies.

Excellence in Execution

Approaches priority setting and setting the stage through the lens of execution

Establishes clarity about the goals accountabilities timelines and next steps; can identify/spot opportunities for real impact on patient and society

Able to be focused and performance driven with clear KPIs

Plans and aligns effectively (steps resources timelines etc.).

Displays a commitment to best practice sharing and setting

Promotes single point of accountabilities

This competency ensures that all tasks are executed efficiently and effectively leading to successful completion of clinical studies.

Builds Effective Teams

Leverages diverse views and manages confronting perspectives to come to the best decision

Creates trust alignment and autonomy

Knows and continuously sets/adjusts the bar for what great looks like and celebrates successes and learns from failures

Consistently looks for diversity in the composition of the team

Building effective teams is crucial for achieving common goals and ensuring high performance levels.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• Minimum of 7 years in the pharmaceutical industry with a PhD or 10 years with a Masters degree.
• Advanced knowledge and practical experience with both widely used and complex clinical study designs. Proficient in common and advanced statistical methodologies including adaptive design techniques.
• Expertise in applying analyzing reporting and interpreting both descriptive and inferential statistics.
• Proficiency with statistical software tools such as SAS R EAST nQuery JMP etc.
• Hands-on experience with CDISC standards and programming based on raw datasets SDTM and ADaM datasets.
• Excellent oral and written communication skills.
• Strong collaborative skills with the ability to work effectively in a global cross-functional team.
• Strong project and time management skills.

Knowledge & Experience (preferred):

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

Education / Certifications (essential):

• Masters degree in statistics biostatistics or relevant field required.

Education / Certifications (preferred):

• PhD in statistics biostatistics or relevant field strongly preferred.

Language(s) (essential):

• Fluent in English.