Minimum MS in Statistics, Biostatistics, or related field (eg., Epidemiology)
3+ years (MS) or 1+ years (PhD) of progressive and relevant experience
Working knowledge of CRF and database development, including attribute assignment and logic checking.
Advanced knowledge of statistical software packages such as SAS, JMP or R.
Knowledge of FDA regulatory requirements for IDE, BLA, PMA and 510K submissions.
Advanced knowledge of applied statistical methods for clinical trials.
Knowledge of applied statistical methods for design of experiments and quality control.
Knowledge of infectious disease, cancer, genomics and common public health issues.
Experience in technical writing.