Proficiency in managing and leading study teams, timelines, and resources;
Expertise in statistical methods and modeling, writing SAPs, and mentoring less experienced statisticians and programmers;
Experience with FDA regulations, questions, advisory boards; experience with ISS/ISEs, BLAs, and NDAs. Strong programming skills related to complex statistical procedures (i.e. multiple imputation, mixed modeling, etc.);
Excellent verbal and written skills;
Demonstrated ability to convey statistical techniques and analysis to non-statistical peers.