Associate Director, Biostatistics
Core
Statistical lead for clinical development programs, providing strategic input on study design, analysis, and regulatory submissions.
Role type
Senior IC biostatistician (clinical development)
Builds
Clinical development plans, statistical analysis plans, regulatory submissions, and scientific documents
Domain
Pharmaceutical/Biotech, Oncology/Hematology
Required skills
Clinical trial methodology, Regulatory guidance (ICH, FDA, EMA, PMDA), CDISC standards, CRO/vendor management, Bayesian methods, Adaptive trial designs, SAS, R
Preferred skills
Oncology/hematology experience, Innovative statistical methods, Marketing application support
Technologies
SAS, R
Responsibilities
Lead statistical interactions with regulatory authorities, Author or oversee statistical sections of protocols and submissions, Provide statistical interpretation of study results, Oversee CRO and external vendor statistical activities, Mentor statisticians and statistical programmers, Evaluate and apply innovative statistical methods
Seniority
Senior, hands-on IC with strategic leadership