Junying Zhang

Junying Zhang Email and Phone Number

Associate Director @ Gilead Sciences
California, United States
Junying Zhang's Location
San Jose, California, United States, United States
Junying Zhang's Contact Details

Junying Zhang personal email

About Junying Zhang

 10 years of SAS programming experience in phase II, III clinical studies Rich experience in supporting regulatory submissions with FDA, PMDA and EMA Hands-on experience with generating SDTM, ADAM, TFLs, and preparing define.xml for Electronic Submissions Manage/Oversee 3 to 10 programmers on each study, including contractors and FSP Experience with cooperating or managing FSP and contractors on studies Expert for Pinnacle 21 Enterprise and has been Gilead P21E trainer for 2 years  Rich experience with POPPK, PK/PD analysis and prepare e-submission package for FDA and PMDA submission Expert in SAS, prior experience of R and Python Gilead subject matter expert on electronic trial master file Proven ability to manage multiple assignments and handle changing priorities in a fast-paced environment.

Junying Zhang's Current Company Details
Gilead Sciences

Gilead Sciences

View
Associate Director
California, United States
Website:
gilead.com
Employees:
14647
Junying Zhang Work Experience Details
  • Gilead Sciences
    Associate Director
    Gilead Sciences
    California, United States
  • Gilead Sciences
    Senior Manager, Statistical Programming
    Gilead Sciences Mar 2023 - Present
    Foster City, Ca, Us
  • Gilead Sciences
    Manager, Statistical Programmer
    Gilead Sciences Mar 2021 - Mar 2023
    Foster City, Ca, Us
    Ÿ Lead programmer for phase II-III Rheumatoid Arthritis and Primary sclerosing cholangitis clinical studiesŸ Generated ADaM datasets and TFLsŸ Communicate with Statisticians, Clinical Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Clinical Pharm to address programming related study deliverablesŸ Lead/Oversee multiple projects for the creation of SDTM, ADaM, TFLs, and define.xml and reviewer's guide.Ÿ Manage/Oversee 3 to 10 programmers on each study, including contractors and FSPŸ Lead the statistical programming support of FDA/EMEA/PMDA regulatory submissions follow CDISC standardsŸ Involved in development of statistical section of Protocol, SAP, review Case Report Forms (CRF) and Data Management documents.Ÿ Prepare and review ISS, ISE for FDA submission and work on related RTQsŸ Oversee outsourced statistical programming activities and cooperate with FSP and contractor on programming activitiesŸ Join Study Management Team meetings to address programming related issues and answer questions for deliverables and timelinesŸ Participated in SAS macro and Linux utility testing and provided inputs on improvementŸ Pinnacle 21 Enterprise trainer and Pinnacle Community co-trainerŸ TMF subject matter expertŸ Regularly do presentation in group meeting on topics like, preparing the PK/PD for FDA submission, lead programmer's checklist, prepare DMC package for double blind study, and P21E issue discussion.
  • Gilead Sciences
    Senior Statistical Programmer
    Gilead Sciences Jan 2018 - Mar 2021
    Foster City, Ca, Us
     Lead programmer for phase II-III HCV, HIV clinical studies Generated ADaM datasets and TFLs Created and reviewed data packages (Define-XML and reviewer's guide) for regulatory submission  Lead programmer for multiple population PK and PK/PD studies and prepare e-submission package for FDA and PMDA Involved in development of statistical section of Protocol, Statistical Analysis Plan, review Case Report Forms (CRF), and Data Management documents. Prepare and review ISS, ISE for FDA submission and work on related RTQs Oversaw outsourced statistical programming activities
  • Gilead Sciences
    Statistical Programmer Analyst Ii
    Gilead Sciences Oct 2014 - Jan 2018
    Foster City, Ca, Us
     Lead/validation programmer for phase II-III HCV clinical studies Generated and validated SDTM, ADaM datasets and TFLs
  • Kaggle
    Kaggle Competitor
    Kaggle Jan 2018 - Mar 2019
    San Francisco, California, Us
    https://www.kaggle.com/junyingzhang20181. Use feature engineering and ridge regression to predict house sales prices2. Exploration data analysis and visualization on Google job skills3. Support vector classier and Gridsearch to classify Iris data with 100% accuracy4. Implement regularized logistic regression to predict whether microchips from a fabrication plant passes quality assurance5. Use anomaly detection algorithm to detect failing servers on a network
  • Statinmed Research
    Statistician
    Statinmed Research Sep 2012 - May 2014
    Dallas, Texas, Us
    • Conduct statistical analysis and programming on large-scale healthcare claims data, e.g., Medicare, Medicaid.• Perform data extraction, integration, cleaning, produce analysis datasets, and generate statistical summary tables and figures.• Conduct descriptive analysis and performed statistical modeling including linear regression, logistic regression and Cox regression, survival analysis, propensity score matching analysis, etc.• Develop project related documents like protocol, statistical analysis plan, PPTs, abstract and poster.

Junying Zhang Skills

Sas Statistics Data Analysis Logistic Regression R Statistical Modeling Matlab Research Linear Regression Sas/sql Sas/macro Sas Programming Vba Outcomes Research Microsoft Office Multivariate Analysis Data Management Meta Analysis Sas Base Meta Analysis Gpower Errors In Variables Model Clinical Trials Python

Junying Zhang Education Details

  • Stony Brook University
    Stony Brook University
    Statistics
  • Stony Brook University
    Stony Brook University
    Quantitative Finance
  • Stony Brook University
    Stony Brook University
    Statistics
  • East China Normal University
    East China Normal University
    Insurance(Specialized In Actuarial Science)
  • East China Normal University
    East China Normal University
    English (Minor)

Frequently Asked Questions about Junying Zhang

What company does Junying Zhang work for?

Junying Zhang works for Gilead Sciences

What is Junying Zhang's role at the current company?

Junying Zhang's current role is Associate Director.

What is Junying Zhang's email address?

Junying Zhang's email address is zh****@****ail.com

What schools did Junying Zhang attend?

Junying Zhang attended Stony Brook University, Stony Brook University, Stony Brook University, East China Normal University, East China Normal University.

What skills is Junying Zhang known for?

Junying Zhang has skills like Sas, Statistics, Data Analysis, Logistic Regression, R, Statistical Modeling, Matlab, Research, Linear Regression, Sas/sql, Sas/macro, Sas Programming.

Who are Junying Zhang's colleagues?

Junying Zhang's colleagues are Cheryl Doriot, Mba, Niyonsaba Ruben, Adam Weinstein, Xi Chen, Pamela Chomsky Rn, Pmp, Clive Finnegan, Furong Wang.

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