The Associate Director leads the full scope of statistical contribution to a clinical development program within a specific therapeutic area
Job Summary
The Associate Director leads the full scope of statistical contribution to a clinical development program within a specific therapeutic area.
This role requires providing statistical thought partnership for innovative study designs including Go-No Go criteria and probability of technical success calculations.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives using plasma fractionation, recombinant protein technology, and cell and gene therapy.
Matching Summary
The Associate Director leads the full scope of statistical contribution to 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 expertise
Regulatory submission experience FDA EMA
SAS and/or R programming knowledge
Nice-to-have
Innovative study design capabilities
CRO management experience preferred
CDISC and data standards familiarity
Oral presentation skills for stakeholders
Matrix environment collaboration skills
Key Requirements
PhD with 8 years experience OR MS with 11 years
Leadership in pre/early/full clinical development strategy
Experience interacting with major regulatory authorities
Track record of innovation in statistical methodology