Data Management Regulatory Affairs

James MeiLiang Yue

*****.**.***@*****.***

SUMMARY

Expert level of experience with TA: CVMD, Oncology, Virology, Neurosciences, Dermatology

From Regulatory Affairs point plan product developing strategies

Learn authority industry guidances and prepare interaction with FDA CDE EMA

Clear communicate across functional sections of organization and geographics area

about overall strategies and plans for lauching the products IND BLA NDA

Interaction with cross function groups of medical affairs, data management, programming, CRO, legal

China US & Global clinical trial experience, RA, Statistics, AI skills.

Developed 10 medicines: Orencia, Pegfilgrastim Biosimilar, Exjade, Chanitix, Rituximab, Baraclude, Valsartin and overseeing a dozen of ongoing trials, especially oncology

Developed/Reviewed technical documents(including legal & biostatistics related

to filing with the authority

Recently trained and refreshed through seminar on RA with real product case for FDA

Experience of CRO and knowledge of FDA/CDE regulations; strong collaborate skills with regulator and registration teams from the field

CORE STRENGTHS

Clinical development strategies regulatory, medical, and statistics

Certified Clinical Pharmocology; Certified Clinical Pharmocology

Cross functions: Data Management, Medical & Regulatory Affairs, PV

Global Solution

Team Building

PASS, SAS Viya IND BLA NDA IB

EDUCATION

Post Graduate Doctor Research: Boston U Medical School (2002-2005)

City University of New York Graduate Center 1993-1996 PhD Program in Experimental Psychology and Clinical science

University of Science and Technology of China and Columbia University Graduate School

MS Quantitative Methodology Computer Science with Specialty on Applied Statistics

1988 – 1991

Paul F. Larzardsfield Fellowship from Columbia University (1990-1991)

Continued Education

1.New Drug Development NDAA

2.Columbia University School of Business Executive Program

3.Pharmacology Biostatistics and Regulatory

Trained by ABBVIE ALC on pharmaceutical Industry

After 2020 Feb served a CRO on 40+ oncology and cadiovascular trials

EXPERIENCE

PROFESSIONAL EXPERIENCE

Associate Director

Overseeing dozens of oncology clinical trials from Innovative biopharma

companies. Coach and lead a team working from protocol statistical plan to report. Support business development & medical team from study design, sample size and power analysis, randomization, to study report and IND or NDA. Interact with Data Management on CRF data collection and database lock. Training new employee on clinical development FDA and CDE guidance topics. Review company functional SOPs for Global submission. Promote company on brand, value and culture. Collaborate with Regulatory and Registration specialists on planning the overall strategies of oncology products development. As a full service CRO, I am the wildcard person for the company to fulfill the needs whenever the clients cares about by collaborating with leaders in mutiple function area within in the organization and experts from industry academics and governments. Design studies and implement incorporate RA and FDA decision makers point of view. Favor Neurosciences

Products developments and strictly oncology products evaluation.

Abbvie, Chicago, IL Sep 2019 -Jan 2020

Principle Clinical Scientist in Data & Statistics

Endpoints selection Design and sample size recommendation

Drafting, updating, commenting of Statistical and the programming plan.

Double-blinded multiple arm stage co-primary and endpoints of clinical trials for submission

Reviewing and commenting statistical analysis report for EudraCT

Reviews specifications of analysis data .

Novartis(Sandoz), Princeton, NJ Oct 2016-Feb 2018

Head Associate, Global Clinical Development

Description: lead and supporting clinical trials in the US, Europe. Provides statistical Leadership, direction and design for global clinical trials. Collaborated with Medical and Regulatory Affairs in BLA submissions to FDA and Company DocBase filing. Endpoints and Statistical Testing Methods Guidance. Led or organized various meeting. Validated delivery from CRO or another department.

Responsibilities:

PK/PD crossover studies design and oncology clinical trials

Translate medical inquiries into Data Presentation Plan for Orencia study

Review update finalize statistical analysis plan and statistical section of protocol

Review and comment TLG CSR shell DVP

BDRM meeting and minutes

Bioequivalent study hypotheses testing method

QA statistical part of CRO delivery for submission (efficacy mixed model and safety domains)

QA ad hoc AE health authority posting

QA results of programming (ADAM/TGL)

Trained Novartis/Sandoz and Clinical development industry-wide best practice SOPs

Bristol Myers Squibb/Pfizer, Greater New York Area, NY

Sr Clinical Statistician Scientist – Biometrics

June 2005 – March 2010

Led a working team to work on Baraclude ISE databases integration and epidemiology analysis to address critical FDA questions about drug safety.

Coordinated and communicated with 3-7staff in charge of individual studies. Reviewed studies data, mapping forward (data transform) programs. Checked the results after integration and solved any problems.

Reviewed datasets, TLG and documentations for NDA submissions.

Documented data processing procedures for projects

UAT clinical trial report system for all TAs TLGs

Support 2 drugs clinical trails

Boston University School of Medicine, Boston, MA

Post Graduate Medical Research

September 2002 – May 2005

Psychiatric diseases substance addiction DSMIV diagnosis and classification Wrote an approach paper on missing data imputing

Trained in medical school program

Most Recent Training: Seminar on Registration Strategies on New Drug Global Development: Thoughts and Practice May 26 2023 Shanghai

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