Location: Gaithersburg, MD
Salary: $165,000 to $185,000
Client company is looking for a Director, Biostatistics to Statistically lead on all aspects of their Products
"Provide Global Statistical Leadership for staff on products according to company standards and external regulations
"Development Design Option and Decision Support
oQuantify, Uncertainty Risk, Value, and Benefit for Emerging Product Profiles
oStatistical work standardization within product compliance.
oOversee Partners/CRO on Deliverables and Quality Standards
"Apply novel statistical approaches for value demonstration and regulatory guidance
"Global relationship development with collaborative groups, consultants, and international opinion leaders.
"Statistical staff technical mentoring/coaching and educational support.
"PhD/MS in Biostatistics, Mathematics
"Experience in Healthcare/Pharma or relevant areas
"Oncology experience desired
"Extensive Regulatory and technical knowledge
"Development, Program Design, Interpretation and Data Analysis Experience
"Submissions and regulatory interaction experience
"Ability to Direct Project work
"Ability to build strong relationships- Polished Communication Skills