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

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
Fluent in English

Director, Biostatistics

Key skills