Drug Safety Scientist- 30% FTE

Drug Safety Scientist required at 30% of FDA.  Must be expert in drug safety statistics.  For the particular asset under development the safety profile is extremely strategic. The main competitor product’s safety profile is not ideal but since there are no other treatments it is the primary product for this condition.  This asset has similar efficacy and a much better safety profile.  Task is to analyze the safety data and present statistical strategy for submission, participate in agency meetings, and act as safety statistician and advisor to the head of clinical development.  Will also interface with head of clinical operations, regulatory and other key stakeholders as needed.  Initial contract for six months, to be extended as needed.