The role involves leading the full scope of biostatistics conduct for a clinical development program within a specific therapeutic area
Job Summary
The role involves leading the full scope of biostatistics conduct for a clinical development program within a specific therapeutic area.
Candidates must provide statistical thought partnership for innovative study designs including Go-No Go criteria and probability of technical success calculations.
CSL Vifor is a global partner specializing in iron deficiency and nephrology therapies with a strong commitment to inclusion and belonging.
Matching Summary
The role involves leading the full scope of biostatistics conduct for a clinical development program within a specific therapeutic area.
Skills & Requirements
Must-have
PhD or MS in Biostatistics
8-11 years drug development experience
Statistical leadership at compound level
Advanced statistical methodologies
Regulatory submission experience
Nice-to-have
Innovative study design expertise
CRO management experience
SAS and R programming knowledge
CDISC standards familiarity
Cross-functional collaboration skills
Key Requirements
PhD or MS degree required
8 years experience with PhD or 11 with MS
Proven track record in regulatory submissions
Experience interacting with FDA/EMA/PMDA preferred