Summary of Experience

• Seasoned PhD statistician and drug developer with quantitative background offering ~28 years pharmaceutical experience.

• Direct hands-on experience in each of drug development phases 1-4.

• Familiarity with both US and China pharmaceutical development eco-system through international assignments.

• Extensive collaboration with various development functions such as medical, regulatory, clinical operations, safety surveillance, clinical pharmacology, health economics, discovery research, marketing, etc.

• Management and oversight of CRO bidding/negotiation/services.

• Multiple IND/NDA/BLA filings experience as lead statistician.

• Regulatory agency interactions experience including end-of-phase-2 meetings, pre-NDA meetings, FDA Advisory Committee hearings, teleconferences for regulatory response, and label negotiation meetings.

• Leadership in multiple due diligence efforts.

• Therapeutic exposure in endocrine, neuroscience, infectious diseases, cardiovascular, oncology, and nephrology areas.

• Extensive experience in rare disease drug development including innovative trial designs and regulatory interaction, bringing several successful drugs to market.

Scope of Consultation 

• Act as internal point of contact and provide oversight to CRO’s Biostatistics/Programming/Data Management functions

  • Guide the development of protocols, SAPs, DMPs, DTPs, etc.

  • Verify the adequacy of statistical analysis methods and implementation

  • Provide insight based on analysis results to drive clinical development decisions, and ensure optimal business outcome

  • Conduct statistical analysis/programming and data management activities

  • Represent the company’s Biometrics function in interactions with regulatory agencies globally and to review regulatory submissions

• Help establish the company’s Biometrics related functions, processes, inspection readiness, compliance, and infrastructure

• Participate in Data Monitoring Committee for critical clinical studies

• Participate in Scientific Advisory Board to provide drug development expertise and strategic input to clinical development plans and study design