Michelle D.
Passionate Data-driven Pharmaceutical Professional| Clinical Data Integrity| Data Governance｜Statistician| Clinical Data| Clinical Trial & Drug Commercial Advanced Analytics
- Role
- Director at BioMarin Pharmaceutical Inc.
- Location
- Carmel, IN, US
- LinkedIn followers
- 500 followers
About Michelle D.
Highly motivated statistician and leader, with 20+ years of global pharmaceutical experiences in clinical data management & statistical analysis efforts in clinical trials, drug commercial advanced analytics, clinical data integrity oversight. I have a proven track record of:* statistical support for clinical trials, multiple NDA submissions, participated in multiple regulatory inspections (FDA, EMA, Korea, etc.).* building and leading a high-performing Quality-by-Design (QbD) clinical data integrity oversight team; providing clinical study data integrity oversight throughout study design, execution, ICFs, computer system configurations, data collection, data management, transformation, analyses, and reporting. Leading development standard operating procedures (SOPs), work instructions, etc.* advanced analytics support for drug commercial insights, providing marketing analytics & cost optimizations, translating analytics outcomes into business insights to guide business decisions, clearly communicating results clearly to senior business leaders, leading efforts to enhance data automation & analytics capabilities, driving strategic initiatives, leading process improvement.* managing team members, vendors and data sources used for analyses; programming in SAS®, R, and SQL
Experience
Director
Nov 2025 — Present
Education
Purdue University
Master of Science - MS, Applied Statistics
2001 — 2003
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