KAIHONG YAO (Mike)

* ********* ******

Jersey City, NJ 07306

Tel: 201-***-****

E-mail: ade84c@r.postjobfree.com

Professional Summary

Specialty: New Drug Development in clinical trials, focus on the most important characteristics of the disease with the Help of FDA’s website and Internet, emphasis on Biostatistics.

Project Management of timeline, member in a project, contracts, statistics, and also in charge of database system and development.

Help in the new drug development and Participate in Study Design and Protocol Development Team, Discuss key elements in the project, such as endpoint selection by using Internet as additional reference, Prepare Protocol Synopsis, and Design statistical section of protocol, including sample size calculation and power estimation, for New Drug Application.

Participate in hiring process and then mentor the staff.

Participate in internal strategical meetings to prepare for FDA Advisory Broad Meeting, and Discuss project issues with former FDA's Directors.

Participate in CRO Selection and then Manage Database Department and Statistical Department of CRO for projects.

Represent pharmaceutical company in project meetings and solve problems for CROs.

Check, (Change if needed,) and then Represent the pharmaceutical company to Sign on all technical documents including the contract of CRO for different drug application(s).

Database Development and Management (Design and Develop CRF, Annotate CRF, Data Specifications, Data Entry Guideline, Edit Check for new drug applications). Direct database managers in CRO for drug applications. Perform Data Validation and Database Lock. Provide my thoughts to Data Mining.

Setup SAS Programming Specifications. And Direct statisticians and SAS programmers in CRO for drug applications. Perform SAS Programs verification (Check Statistical Results including Tables/Listings/Graphs, SAS programs and Macros), make sure no error in the project before submission or before publication.

Most recently, did Phase I to Phase III Oncology Studies at different companies and Phase I - Phase IV studies in other Therapeutical Areas. Performed PK/PD and Safety Analyses for Phase I Studies.

Search and Confirm a subset of data: Patients with a Biomarker of the Cancer, along with its better treatment result.

Experienced in statistical genetics, Did a project for Genetic Disease – Down Syndrome -- with biomarker: chromosome 21.

Helped pharmaceutical company to win FDA’s approval, by sending my letter to FDA about statistical issues in clinical trial.

Sent my letter to FDA about Mild Cognitive Impairment (MCI) / Early Alzheimer’s Disease.

Perform Data modelling, then use the model to predict and reduce the sample size for a phase IIIb study, present the result to the top leaders then amend the protocol.

Develop Statistical Analysis Plan (SAP) with Mock of Tables/Data Listings and Graphics.

Generate Statistical Tables, Data Listings and SAS Graphics (T/L/G) for NDA Submission,

Use different Statistical Methods for Multiple Comparison in NDA Submissions.

Participate in CSR Writing Team and Submission Team and then NDA Submission to FDA, EMA, as well as PMDA.

Discuss Statistical Issues with FDA, and Answer FDA’s meta-analysis question and other tough questions.

Participate in National Meeting of Drug Presentation and Answer Doctors' Questions during breaks.

Participate in major scientific meetings for new drug development, and Help to publish study results in magazines

Launch a New Project and then Participate in investigator meeting and Provide my thoughts to the Project Director.

Participate in development of Standard Operation Procedure (SOP).

Prioritize my work daily, and then prepare every piece of my work in details before go to office everyday.

Have the knowledge of FDA/ICH guidance such as Bioequivalence/Biosimilarity, Non-Inferiority in drug applications.

Have the experience of Bayesian Adaptive Design with Interim Analysis.

Answer Japanese FDA’S questions about NDA submission by generating additional data analyses, recreate integrated summary results of clinical efficacy and clinical safety from existing ISE and ISS of previous NDAs.

Have the knowledge and wrote an article of New Drug Discovery and Development Process.

Draft Clinical Study Report (CSR) including synopsis, then finalize and sign off the CSR.

Search Information in the Internet to solve problem.

Professional Experience

April, 2019 – June, 2019 Immunomedics, 410 American RD, Morris Plains, NJ 07950

Title: Contract Biostatistician

Review Protocol for Treatment of Stage IV, Metastatic Cancer Patients, Phase I/II, Dose-Escalation Study.

Review Statistical Analysis Plan (SAP) and Data Sets (with CDISC/ SDTM and ADaM),

Review PK/PD and Safety Data Sets. Review Interim Analysis, and its Report.

Participate in Data Management Meetings.

Provide Statistical Analyses for the Final Result.

Interviewed on April 1st, then Prepared to work, Hired in May, the Contract ended in June 2019, because the project does not work for this stage of disease.

Mar.1, 2018 - Mar. 30, 2018, ENTERIN Pharmaceuticals, 2005 Market Street, Philadelphia PA 19103

Title: Contract Biostatistician Consultant

Review protocol and check database (in the form of Electronic Data Capture (EDC)) for a Phase I/2a study.

Develop SAP with Mock of Tables/Data Listings, for Efficacy, PK/PD and Safety Analyses to a Single-Dose, Multiple-Dose and Dose Escalation Study.

Using Bayesian Adaptive Design with interim analysis; Generate Statistical Interim Report, then amend the

protocol, change the Sample Size, add a higher dose in the study.

Consulting Statistical Key Issues, including Sample Size on further study in development.

Mission is accomplished at this brand new pharmaceutical company.

Dec. 2014 – Dec. 2014, Princeton Pharmatech (CRO) 43 Princeton Hightstown Rd, Princeton Jct, NJ 08550

Title: Contract Biostatistician (Work at home)

Review protocol and check database for a Phase I study, using Ointment on Skin Infectious Disease.

Develop SAP with Mock of Tables/Data Listings, then the job is done,

Apr. 2013 – Aug. 2013, OHR Pharmaceutical Inc. 489 Fifth Avenue, New York, NY 10017

Title: Biostatistician (a Three Months Contract, but extended for another month, ended on August 9th, work at home)

Review protocol and check database for an Early Phase: Phase II oncology study

Develop SAP with Mock of Tables/Data Listings and Graphics, then clean the data files and generate statistical T/L/G,

Search Background Information about the Drug in the Internet then use it in the draft of Clinical Study Report (CSR),

Draft the CSR including synopsis, then finalize and sign off the CSR.

Dec 2007 – Jun. 2011, Laxai (CRO), Hadley Park, 4041A, Hadley Road, South Plainfield, NJ 07080

Title: Lead Biostatistician (Contract)

Provide leadership to the team for Clinical Trials.

Review protocol and database structure; Review data sets in CDISC with options, such as SDTM and ADaM for clinical projects,

Responsible for SAP development with Mock of Tables/Data Listings and Graphics,

Setup SAS Programming Specifications. And Help the SAS Programmer to generate T/L/G for clinical Studies, by creating detailed programming specification, Check their results.

Represent the company to Sign on technical documents,

Discuss statistical issues with Sponsors for clinical projects,

Did a Phase I, Dose-Escalation, New Cancer Drug study (with PK/PD and Safety analyses) and then Draft a Clinical Study Report including synopsis.

Also did several other studies including /a Case Control /an Observational study/a Retrospective study with a huge data set.

Apr 2007 – Aug 2007, PRD / Johnson & Johnson, 920 Route 202, Raritan, NJ 08869

Title: Contract Statistician

Responsible for after NDA submission to PMDA (Japanese FDA), Answer Japanese FDA’s questions about NDA submission of an oncology drug, Phase III, bioequivalence studies, generate additional analyses, by combining 2

Phase III studies then analyze Safety and Efficacy, that is, meta-analysis (US/FDA does not ask these questions.)

Check from Protocol to SAP; from Protocol to Database; and then check T/L/G, including CSR before answering PMDA’s questions about the NDA submission.

Search and Confirm a subset of data: Patients with a Biomarker of the Cancer, along with its better treatment result.

In addition, help other groups for NDA submissions to US/FDA and answer US/FDA questions about patients' profile.

Mission is accomplished.

Sep 2006 – Nov 2006, Clinsys (CRO), One Connell Drive, Suite 3000, Berkeley Heights, NJ 07922

Title: Senior Biostatistician

Review protocol and Check the sample size; then Developed SAP;

Insure data quality, Supervise SAS programmer; Validate TLGs; Interface with clients regarding statistical issues;

Prepare the statistical sections of Clinical Study Reports (with my boss) for an Early Phase: Phase II oncology study.

Sept 2002 – Apr. 2005, Eisai Inc, Glenpointe Centre West, 500 Frank W. Burr Blvd, Teaneck, NJ 07666

Title: Senior Biostatistician

Responsible in general: statistical portion and also in charge of database management for every project.

Especially responsible: for Project Management of timeline, member in a project, contracts, statistics, database system and its development.

Participate in hiring process and then mentor the staff.

Help in the new drug development by using biostatistics.

Prioritize my work daily, and then prepare every piece of my work in details before go to office everyday.

Help in the new drug developmen, and Participate in Study Design and Protocol Development Team, Discuss key elements in the project, such as endpoint selection by using Internet as additional reference, Prepare Protocol Synopsis, and Design statistical section of protocol, including sample size calculation and power estimation, for New Drug Application.

Participate in internal strategical meetings to prepare for FDA Advisory Broad Meeting, and Discuss project issues with former FDA's Directors.

Participate in CRO Selection and then Manage Database Department and Statistical Department of CRO for projects.

Represent pharmaceutical company in project meetings and solve problems for CROs.

Check, (Change if needed,) and then Represent the pharmaceutical company to Sign on all technical documents including the contract of CRO for different drug application(s).

Database Development and Management (Design and Develop CRF, Annotate CRF, Data Specifications, Data Entry Guideline, Edit Check for new drug applications). Direct database managers in CRO for drug applications. Perform Data Validation and Database Lock. Provide my thoughts to Data Mining.

Setup SAS Programming Specifications. And Direct statisticians and SAS programmers in CRO for drug applications. Perform SAS Programs verification (Check Statistical Results including Tables/Listings/Graphs, SAS programs and Macros).

Check Protocol, Check SAP, Check Database, and then check T/L/G, and also Check CSR, if developed by other people, make sure no error in the project before submission or before publication.

Develop Statistical Analysis Plan (SAP) with Mock of Tables/Data Listings and Graphics.

Participate in CSR Writing Team and Submission Team and then NDA Sbmission to FDA and EMA.

Discuss Statistical Issues with FDA, and Answer FDA’s meta-analysis question and other questions.

Helped pharmaceutical company to win FDA’s approval, by sending my letter to FDA about statistical issues in clinical trial.

Participate in National Meeting of Drug Presentation and Answer Doctors' Questions during breaks.

Participate in major scientific meetings for new drug development, and Help to publish study results in magazines

Perform data modelling, then use the model to predict and reduce the sample size for a phase IIIb study, present the result to the top leaders then amend the protocol.

Did one project using Bayesian Adaptive Design with Interim Analysis.

Participate in development of Standard Operation Procedure (SOP), Participate in budget meetings.

Present Data for Interim Analysis and Final Analysis.

Did a project for genetic disease – Down Syndrome--- with biomarker: chromosome 21.

Help Other Dept. to prepare documents for FDA’s Inspection.

Explain statistical information to non-statisticians.

Oct 2001 – Dec 2001, Pfizer Inc. 50 Pequot Avenue, New London, CT 06320

Title: Clinical SAS Programmer Consultant

Responsible for Review Protocol then help to set analysis pooled (derived) data sets.

Check the Statistical Analysis Plan; and then Check SAS Programs, Macros, SAS Graphics and Their Results, find errors in SAS Graphics outputs, then correct errors for a New Cardiovascular Drug Submission to FDA by using my own SAS programs.

Jun 1999 – Mar 2001, Barton & Polansky Associates Inc. (CRO) 345 Park Avenue, New York, NY 10154

Title: Clinical Data Analyst and SAS Programmer

Responsible for Data Analyses and SAS Programming for New Drug Applications.

Review Protocol and CRF then Help to set up Statistical Analysis Plan for New Drug Applications; Program in SAS to Generate Statistical Tables, Data Listings and SAS Graphics for New Drug Applications. Submitted NDA to FDA.

Check other people’s SAS Programs, Macros and Results then Correcting errors and Rerun the Programs for Several New Drug Applications.

Perform PK/PD and Safety Analyses for Phase I Studies

Participate in Statistical Clinical Report Writing Team.

Jun 1998 – Apr 1999, Target Health Inc. (CRO) 261 Madison Avenue, 24th Floor, New York, 10016

Title: Manager of Biostatistics

Review Protocol and CRF then Program Statistical Tables, Data Listings for New Drug Applications.

Participate Statistical Report Writing; Submitted NDA to FDA.

Directly contacted by FDA for protocol amendment in a NDA submission; during a three-way teleconference, made a suggestion to FDA, which helped the pharmaceutical company to win the FDA's approval.

Generate Randomization Schedule.

Transfer Data to SAS Data Sets.

Education

MS May 1998 Dept. of Applied Math & Statistics, SUNY Stony Brook

MS August 1987 Dept. of Mechanical Engineering, SUNY Stony Brook

Technical Skills

Statistical Packages: SAS, SPSS, S+, Excel ( for simulation), R, N-Query, WinNonlin (for PK Data Analysis)

Database Systems Clintrial, Oracle, ACCESS, ClinTrial

Statistical Programs

New Cancer Drugs to treat different Cancers- Phase I - Phase III (SAS)

New Drug Application for Alzheimer’s Disease - Clinical Trial (SAS)

New Drug Application for Parkinson’s Disease - Clinical Trial (SAS)

New Drug Application for Depression - Clinical Trial (SAS)

New Drug Application for Epilepsy’s Disease - Clinical Trial (SAS)

New Drug Application for Mild cognitive Impairment (MCI) - Clinical Trial (SAS)

New Drug Application for Schizophrenia’s Disease - Clinical Trial (SAS)

New Drug Application for Pain - Clinical Trial (SAS)

New Drug Application: Vaccine for Infectious disease - Clinical Trial (SAS)

New Drug Application for Asthma/ Respiratory Disease - Clinical Trial (SAS)

New Drug Application for Cardiovascular Disease–to lower bad cholesterol- Clinical Trial (SAS)

New Drug Application for Stroke Reduction and Heart Attack Prevention- Clinical Trial (SAS)

New Drug Application for Gastroenterology Disease: Stomach Ulcer (inflammation disease) - Clinical Trial (SAS)

New Drug Application for Overweight/Obesity and Diabetes - Clinical Trial (SAS)

New Drug Application: Female Infertility, a Phase III clinical Study - Clinical Trial (SAS)

New Drug Application: New Vaccine for AIDS/HIV and Infection disease - Clinical Trial (SAS)

New Drug Data Listings to FDA – Clinical Trial (SAS)

References: Available upon request.

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