Junying Zhang Email and Phone Number
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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.
Gilead Sciences
View- Website:
- gilead.com
- Employees:
- 14647
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Associate DirectorGilead SciencesCalifornia, United States -
Senior Manager, Statistical ProgrammingGilead Sciences Mar 2023 - PresentFoster City, Ca, Us -
Manager, Statistical ProgrammerGilead Sciences Mar 2021 - Mar 2023Foster City, Ca, Us Lead programmer for phase II-III Rheumatoid Arthritis and Primary sclerosing cholangitis clinical studies Generated ADaM datasets and TFLs Communicate with Statisticians, Clinical Data Managers, Clinical Operations, Medical Monitors, Medical Writing and Clinical Pharm to address programming related study deliverables Lead/Oversee multiple projects for the creation of SDTM, ADaM, TFLs, and define.xml and reviewer's guide. Manage/Oversee 3 to 10 programmers on each study, including contractors and FSP Lead the statistical programming support of FDA/EMEA/PMDA regulatory submissions follow CDISC standards Involved in development of statistical section of Protocol, SAP, review Case Report Forms (CRF) and Data Management documents. Prepare and review ISS, ISE for FDA submission and work on related RTQs Oversee outsourced statistical programming activities and cooperate with FSP and contractor on programming activities Join Study Management Team meetings to address programming related issues and answer questions for deliverables and timelines Participated in SAS macro and Linux utility testing and provided inputs on improvement Pinnacle 21 Enterprise trainer and Pinnacle Community co-trainer TMF subject matter expert 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. -
Senior Statistical ProgrammerGilead Sciences Jan 2018 - Mar 2021Foster 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 -
Statistical Programmer Analyst IiGilead Sciences Oct 2014 - Jan 2018Foster City, Ca, Us Lead/validation programmer for phase II-III HCV clinical studies Generated and validated SDTM, ADaM datasets and TFLs -
Kaggle CompetitorKaggle Jan 2018 - Mar 2019San Francisco, California, Ushttps://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 -
StatisticianStatinmed Research Sep 2012 - May 2014Dallas, 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
Junying Zhang Education Details
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Stony Brook UniversityStatistics -
Stony Brook UniversityQuantitative Finance -
Stony Brook UniversityStatistics -
East China Normal UniversityInsurance(Specialized In Actuarial Science) -
East China Normal UniversityEnglish (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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