Director, Biostatistics

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 Ipsen's 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 CRO’s 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 Master’s 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):

• Master’s 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.