Job Purpose/ Summary: Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist,
Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation
What Youll Do: Assist with the development and modification of department SOPs and work instructions Assist with training new Biostatistics employees; mentor and assist junior level Biostatisticians Develop study bids and changes in scope for Biostatistics