Director, Biostatistics

Ipsen Pharma

Paris or London

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.

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.

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.