Director, Biostatistics
Ipsen
full-time
Posted on:
Location Type: Office
Location: Cambridge • United Kingdom
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Job Level
About the role
- 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
Requirements
- 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
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biostatisticsclinical study designstatistical methodologiesdescriptive statisticsinferential statisticsproject planningdata validationQCregulatory submissionsexploratory analysis
Soft Skills
communicationcollaborationproject managementtime management