KAIHONG Yao

Dear Sir/Madam,

As you probably know that

When working at Eisai, (a Japanese Pharmaceutical Company in Northern NJ), there was no Director of Biostatistics, no SAS Programmer and no Database Manager in house.  And I was the only statistician in the company, because my boss found me capable to do all statistics and clinical database. That’s why he did not hire anyone else, but loaded the work on my shoulder. So, I represented Eisai's Statistical Dept. and Data Base Dept. to do everything, including sign on all technical documents. This job usually belongs to a Director of Biostatistics in other pharmaceutical companies.   

 At Eisai, my title was Sr. Biostatistician, but my function was a Director of Biostatistics.

Working at Eisai, I handled more than 15 projects in clinical trials. About half of the projects, we started from Beginning, from study design and protocol development. So, I participated in study design and Protocol development team, discussed key elements in the protocol with the team, including sample size calculation and power estimation then I prepared synopsis, and designed statistical section of Protocol.  After that I developed SAPs sometimes. Other times I authorized the SAP. We all sourced out to CROs. My responsibilities at Eisai included managing the statistical department and database department in CRO for our every project.  At Eisai, I directed statisticians and SAS programmers, I directed database managers in CROs for drug applications. I performed SAS Programs verification, (Check Statistical Results including Tables, Data Listings Graphs, SAS programs and Macros, by using my own SAS Programs), and performed Data Validation and Database Lock. And I did everything between (that is, between the beginning of a project, and at the end of the project, where the end of the project is that I participated in study report write team and submission team, wrote statistical section in report, then submitted NDA to FDA, submitted to EMEA) with success. 

Besides, I had several times to discuss statistical issues with US/FDA and answer US/FDA’s tough questions.  

Hope I can use my experience to work for you. 

Mike

Dear Sir/Madam,

My specialty: 

1. New Drug Development in clinical trials, focus on the most important symptom of the disease, ask questions to myself first: What …? How …? Why …? then try to answer these questions with the Help of FDA’s website and Internet, emphasis on Biostatistics.
2. Project Management of timeline, member, contracts, statistics, and also in charge of database system and  development. 
3. Participate in Study Design and Protocol Development Team; Lead statistical discussion in protocol development; such as endpoint selection by using Internet as an additional source; Setup hypothesis test; Calculate Sample Size (with Power); Prepare Protocol Synopsis, and then Design statistical section in protocol for New Drug Applications.

Mike

MS in Statistics, from State University of New York at Stony Brook, 1998

MS in Mechanical Engineering, from State University of New York at Stony Brook, 1987