Director, biostatistics

Director, Biostatistics

Division / Function: R&D / Biostatistics / Clinical Science / Biometrics

Manager’s Job Title: Senior Director, Biostatistics

Location: Paris, FR - London, UK - Cambridge, US


Summary & Purpose of the Position

The Director of Biostatistics will work in a cross‑functional team, 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. The role is pivotal in advancing Ipsen's mission to improve patient outcomes through innovative oncology treatments. The Director will 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.


Main Responsibilities & Technical Competencies

* Lead as project‑level lead biostatistician in cross‑functional team(s), providing strategic support to Ipsen asset teams, authoring and reviewing key study documents (protocol, statistical analysis plan, dataset specifications, clinical study report, publications, regulatory submissions).
* Contribute to project planning; collaborate with internal and CRO team members to coordinate planning and execution of biostatistics deliverables with quality and within timelines.
* Provide oversight and guidance to ensure CRO partners understand the clinical data and summarization approaches. Validate and QC CRO’s work to ensure the quality and accuracy of statistical deliverables.
* Prepare and validate analyses for regulatory documents and scientific articles; support internal ad‑hoc and exploratory analysis.
* Maintain excellent verbal and written communication within the group and across functional areas.


Key Technical Competencies Required

* Strong attention to detail, excellent direct communication skills, strong interpersonal skills, and cross‑cultural understanding and sensitivity.
* Ability to see the big picture while keeping an eye on detail.
* 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.


Behavioural Competencies Required


Ensures Accountability

* Ensures single accountable referents per task/project/outcome irrespective 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 rather than consensus.
* Takes personal accountability for decisions, actions, successes, and failures, fostering the same for others.
* Follows through on commitment and ensures others do the same.


Communicates Effectively

* Asks open questions, digs deeper, shows care and respect for different perspectives, and relates to other points of view.
* Communicates transparently, tells it how it is while keeping the communication respectful.
* Builds clear, crisp messages with structure and focus; uses visual communication and storytelling to make messages easy to digest and connect with outcomes.
* Demonstrates gravitas.


Collaborates

* Collaborates and communicates without boundaries, continuously removing organizational barriers.
* Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset.


Excellence in Execution

* Approaches priority setting and execution from the lens of execution.
* Establishes clarity about goals, accountabilities, timelines, and next steps; can identify opportunities for real impact on patient and society.
* Focused and performance‑driven with clear KPIs.
* Plans and aligns effectively (steps, resources, timelines).
* Displays a commitment to best practice sharing and setting.
* Promotes single point of accountabilities.


Builds Effective Teams

* Leverages diverse views, manages confronting perspectives to reach best decisions.
* Creates trust, alignment, and autonomy.
* Sets/adjusts bar for what greatness looks like, celebrates successes, and learns from failures.
* Consistently looks for diversity in team composition.


Knowledge & Experience (essential)

* Minimum 7 years in the pharmaceutical industry with a PhD, or 10 years with a Master’s degree.
* Advanced knowledge and practical experience with 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 descriptive and inferential statistics.
* Proficiency with statistical software (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; effective in a global cross‑functional team.
* Strong project and time‑management skills.


Knowledge & Experience (preferred)

* Rare disease drug‑development experience highly desired.
* Regulatory submission (US FDA, EMA, PMDA) experience highly desired.


Education / Certifications (essential)

* Master’s degree in statistics, biostatistics or related field required.


Education / Certifications (preferred)

* PhD in statistics, biostatistics or related field strongly preferred.


Language(s) (essential)

* Fluent in English.
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