Medical Device Clinical Trial

SUMMARY OF EXPERIENCE:

Over ** years of experience in pharmaceutical industry as a biostatistician

Experienced in clinical trial: phase 1, 2, 3 and 4 in various therapeutic areas including oncology, ophthalmology, cardiovascular disease, medical device, dermatology, diabetes, CNS et al.

Lead statistician responsible for studies from start-up through to submission. Seeing out projects/ studies end to end.

Experienced in submission: supporting submission package, BIMO SAP, ISS/ISE SAP, data review guideline; joining study design, protocol/SAP discussing meeting with FDA; answering statistical questions.

Experienced in application of CDISC data standards. Most of the studies experienced follow CDISC data standards

Experienced in PK and BE data analysis and summaries

Experienced in survival analysis, common hypothesis tests (parametric and non-parametric), ANOVA models, and regressions (glm, logistic, cox, mix, genmod) analysis

Efficient in SAS base, macro facility, SQL, ODS, Graph; R language; Bayesian method

Experienced in medical writing and medical review

Strong background in biological research and medicine

PROFESSIONAL EXPERIENCE:

Principal Biostatistician, Apr 2024– Present

REGENERON

(Initial 6 month contract extension potencial), home based.

As lead biostatistician for one phase 1 and one phase 3 studies (oncology immunotherapy studies):

Study designing: sample size calculation, futility analysis boundary, alpha spending function for interim analysis, etal.

Document review: protocol, CRF, DMP, SDTM/ADaM specifications.

Development of SAP and TLF mock shells

Work with the programmer/clinical/medical/safety/regulatory team to complete ISS analysis

Review/validate outputs and datasets

Principal Biostatistician, Jan 2019– Apr 2024

Novartis Pharmaceuticals Corporation

(Initial 12 month contract extended yearly), home based

As study lead biostatistician:

(Phases 1-3, Oncology immunotherapy)

Responsible for studies from start-up through to submission.

Prepare the timeline for biostat/prog deliverables

Write a statistical analysis plan and TLFs shells

Prepare ADaM specs and review SDTM specs

Conduct analysis using SAS

Review protocol, CRF, SAP, and CSR

Sample size/Power calculation and study designs

Review and QC data and analysis results (TFLs)

Write statistical section of protocol and clinical study report

Principal Biostatistician, May 2017– Jan 2019

Syneos Health

4800 Falls of Neuse, Raleigh, NC 27609

As study lead biostatistician, worked on 4-6 studies at same time on average

(Phases 1-3, Oncology, CNS, Diabetes, Rare disease (Barth syndrome)….)

Prepare the timeline for biostat/prog deliverables

Write a statistical analysis plan and TLFs Specification

Prepare ADaM specs and TLF specs

Conduct analysis using SAS

Review protocol, CRF, SAP, and CSR

Sample size calculation and develop randomization schedule

Review and QC data and analysis results of key study endpoints

Write statistical section of clinical study report

Principal Biostatistician, May 2014– May2017

PAREXEL International

3001 S Hanover St, Baltimore, MD 21225

As study lead biostatistician, worked on 2-6 studies at same time

(Phases 1-3, Oncology, Medical Device, Neurology, arthritis…)

Write a statistical analysis plan and TLFs Specification

Conduct analysis

Lead biostatistician for 28 studies

Review protocol, CRF, SAP, ADaM specs and CSR

Sample size calculation and develop randomization schedule

Review and QC data and analysis results of key study endpoints

Write statistical section of clinical study report (Advanced Breast Cancer)

Prepare FDA submission package.

Senior Biostatistician, Jan 2013 – July 2014

Eisai Pharmaceutical Company, Woodhill Cliffs, NJ

Write a statistical analysis plan, conduct analysis (One Phase I: Solid Tumor; One Phase III: Advanced NSCLC))

Lead ISS analysis (Advanced Breast Cancer)

Literature review and conduct meta-analysis (NSCLC, Phase III Studies)

Apply IPCW method to survival analysis

Review and QC data and analysis results of main study endpoints

Write statistical section of clinical study report (Advanced Breast Cancer)

Prepare FDA, EMA and PMDA submission package

Lead Biostatistician, Director of Clinical Operation, Jan 2010 – Dec 2012

Shenzhen SiBiono GeneTech Co., Ltd, Shenzhen 518057, China

Involve in two phase III study (P53 gene therapy for Head and Neck Cancer, Lung Cancer) and one phase IV study (P53 gene therapy for Head and Neck Cancer)

Manage and conduct clinical trial

Design and prepare study protocol and design CRFs

Prepare statistical analysis plane and conduct analysis

Write clinical study report

Communicate with SFDA

Prepare SFDA submission package

Support Marketing

Biostatistician, Feb 2007 – Jan 2010

RPS, Fort Washington, PA 19034

Write statistical analysis plan

Sample size calculation and write the statistical section of protocols and clinical study report

Conduct analyses using SAS

Prepare SAS analysis macros

Communicate with the team of data management, medical directors, medical writers and FDA

Clinical Biostatistician, May 2006 – Feb 2007

Biostatistics Core in Moffitt Cancer Center and Research Institute, Tampa, Florida

Conduct statistical analysis for pre-clinical, pilot clinical and clinical studies

Prepare tables, graphs and analysis reports

Conduct size and power calculations using standard formula and SAS proc power and proc glmpower procedures

Participate in clinical study design and development of protocol

Write statistical analysis section of clinical study reports (CSR), grant proposals and medical manuscripts

Biostatistician, Jan 2003 – May 2006

BioStat International, Inc., Tampa, Florida

Create TLGs using SAS

Prepare SAP and TLG shells

Derive analysis data sets

Validate and edit-check data sets and TLGs

Code adverse event (AE) and medication

Analysist and Medical Writer, Feb. 2001– Jan 2003

Axiomworldwide(now Excite), Inc., Tampa, Florida

Collect data for DRX900 medical device treating back/neck pain and conduct statistical analysis

Prepare tables, lists, and graphs using SAS programs

Write clinical study reports (CSR) and medical manuscripts

Reviewing literatures

Prepare marketing materials and support marketing

Biological Scientist III, July 2000 – Feb. 2001

Drug Discovery Program, Moffitt Cancer Center & Research Institute

Post Doctoral Fellow, August 1998 – July 2000

Drug Discovery Program, Moffitt Cancer Center & Research Institute

Associate Professor/Surgeon, Aug. 1996 – July 1998

Department of Surgery, Beijing Tian Tan Hospital, China

Attending Surgeon, July 1990 – July 1993

Department of Surgery, Huhehoto Hospital, Inner Mongolia, China

Resident, Sep. 1985 – July 1990

Department of Surgery, Second Affiliated Hospital of Inner Mongolia Medical University, China

EDUCATION:

MPH, July 2001 – May 2005, Department of Biostatistics and Epidemiology, College of Public Health, University of South Florida, Tampa, Florida. GPA3.9/4.0.

PhD, July 1993 – July 1996, Oncology, Sun-Yat Sen University of Medical Sciences, China.

MD, Sep. 1980 – July 1985, Medicine, Inner Mongolia Medical University, China.

LANGUAGE SKILLS:

English: fluent; Chinese: fluent

PUBLICATIONS

1. Qi X, Chang Z, Song J, Gao G, Shen Z. Adenovirus-mediated p53 gene therapy reverses resistance of breast cancer cells to adriamycin. Anticancer Drugs. 2011 Jul;22(6):556-62.

2. Gao G. Macro for checking if variable length and labels, and character values meet FDA transport file requirements. submitted to SUGI. 2008 June.

3. Patwari P, Gao G, Lee JH, Grodzinsky AJ, Sandy JD. Analysis of ADAMTS4 and MT4-MMP indicates that both are involved in aggrecanolysis in interleukin-1-treated bovine cartilage. Osteoarthritis Cartilage. Apr;13(4):269-77.

4. Gui G, Plaas A, Thompson VP, Jin S, Zuo F, Sandy JD. ADAMTS4 (aggrecanase-1) activation on the cell surface involves C-terminal cleavage by glycosylphosphatidyl inositol-anchored membrane type 4-matrix metalloproteinase and binding of the activated proteinase to chondroitin sulfate and heparan sulfate on syndecan-1. J Biol Chem. 2002 Mar 12;279(11):10042-51.

5. Gui Gao, Jennifer Westling, Vivian Thompson, Troy Howell and John D. Sandy. Activation of the aggrecanase and versicanase activity of ADAMTS-4 BY C-terminal truncation. J. Biol. Chem. 277, 110**-*****.

6. David MS, Gao G, and Dou QP. Regulation of tumor cell apoptotic sensitivity during the cell cycle. Int. J Mol. Med. 6, 503-507 (2000).

7. Gao G, and Dou QP. Bax is cleaved and activated during apoptosis. J. Cell Biol. 80, 53-72 (2000).

8. Reichert TE, Shigeki N, Yoshiro K, Stanson J, Gao G, Dou QP and Whiteside TL. Interleukin-2 expression in human carcinoma cell lines and its role in cell cycle progression. Oncogene 19, 514-525 (2000).

9. Gao G, and Dou QP. G1 phase-dependent _expression of Bcl-2 mRNA and protein correlates with chemoresistance of human cancer cells. Molecular Pharmacology, 58, 1001-1010 (2000).

Contact this candidate