Gaithersburg, MD 20878
Location: Gaithersburg, MD
Salary: $160,000 to $180,000
Contact: Nihar Parikh, email@example.com
-Provide Global Statistical Leadership for staff on products according to company standards and external regulations
-Development Design Option and Decision Support
-Quantify, Uncertainty Risk, Value, and Benefit for Emerging Product Profiles
-Statistical work standardization within product compliance.
-Oversee 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, etc.
-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