Gaithersburg, MD 20878
Nihar Parikh, email@example.com
-Indication lead and global submissions, statistical contributions to design
-Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation.
-Oversee Partners/CRO on Deliverables and Quality Standards
-Apply 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 and Oncology, Respiratory, Cardiovascular, Diabetes or similar therapeutic area
-Experience in statistical expertise to complex problems; extensive Regulatory and technical knowledge
-Experience in Development, Program Design, Interpretation and Data Analysis
-Submissions and regulatory interaction experience
-Proven leadership experience