Image of Jianping He

Jianping He

Clinical Trial Manager

Principal Biostatistician at Parexel

Washington D.C. Metro Area

Section title

Jianping He's Email Addresses & Phone Numbers

Jianping He's Work Experience

Beijing Fourth Pharmaceutical Corporation

Clinical Trial Manager

January 1995 to August 1999

Beijing City, China

IQVIA

Sr Biostatistician

May 2016 to July 2017

Durham, North Carolina

Children's National Health System

Biostatistician

August 2005 to May 2016

Washington D.C. Metro Area

Jianping He's Education

Beijing Medical University

Bachelor of Science (BS), Pharmaceutics

The George Washington University

Master of Science (MS), Biostatistics

2003 to 2005

Peking University

Bachelor of Science (BS), Pharmaceutics

Jianping He's Professional Skills Radar Chart

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Jianping He's Estimated Salary Range

About Jianping He's Current Company

Beijing Fourth Pharmaceutical Corporation

Responsible for clinical trial research protocol design for new drug; coordinated with the clinical research sites; performed clinical research data analysis; and prepared and submitted the new drug application to CFDA (China’s FDA). Completed 4 new drug’s clinical trial study and submitted 4 new drug applications to SFDA.

Frequently Asked Questions about Jianping He

What company does Jianping He work for?

Jianping He works for Beijing Fourth Pharmaceutical Corporation


What is Jianping He's role at Beijing Fourth Pharmaceutical Corporation?

Jianping He is Clinical Trial Manager


What is Jianping He's personal email address?

Jianping He's personal email address is j****[email protected]


What is Jianping He's business email address?

Jianping He's business email addresses are not available


What is Jianping He's Phone Number?

Jianping He's phone (206) ***-*317


What industry does Jianping He work in?

Jianping He works in the Pharmaceuticals industry.


Who are Jianping He's colleagues?

Jianping He's colleagues are Yin Kean, Adam Young, Leela Aertker, Nadra PhD, Chris Smith, David Riddle, David Bushnell, Bhaskar Rednam, Pauline Surrel, and David Coblentz


About Jianping He

📖 Summary

Clinical Trial Manager @ Beijing Fourth Pharmaceutical Corporation Responsible for clinical trial research protocol design for new drug; coordinated with the clinical research sites; performed clinical research data analysis; and prepared and submitted the new drug application to CFDA (China’s FDA). Completed 4 new drug’s clinical trial study and submitted 4 new drug applications to SFDA. From January 1995 to August 1999 (4 years 8 months) Beijing City, ChinaSr Biostatistician @ IQVIA o Act as point of contact to client regarding all deliverables, such as project plan, the Trial Level Safety Review (TLSR) report, Data Monitoring Committee (DMC) report, Interim Analysis (IA) report and Final Analysis Report. o Develop statistical analysis plans (SAP), LoT, programming specification for TLF shell of TLSR, DMC, IA and Final Analysis Reporto Write statistical sections of integrated reportso Act as team lead for single complex studies or groups of studies and responsible for all deliverables to cliento Set and lead team meetings on TLFs and deliverables outputo Provide advice to programming team on SAS programming of TLSR, DMC, IA and Final Analysis report.o Attend the study meeting with client and provide input to case report form design, critical data and validation checks.o Manage customer relationships.o Provide training and guidance to statistical analyst and programmer.• Major accomplishments include o Phase 1, a open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of avelumab in subjects with metastatic or locally advanced solid tumoro Phase 3, a randomized double-blind, placebo controlled study of sunitinib in subjects with at high risk of recurrent renal adjuvant cancero Phase 4, a single-arm open-label multi-center study of the efficacy and safety of sunitinib in patients with progressive advanced metastatic pancreatic neuroendocrine tumorso Phase 3, a double-blind efficacy and safety study of the phosphodiesterase type 5 inhibitor tadalafil in pediatric patients with pulmonary arterial hypertension From May 2016 to July 2017 (1 year 3 months) Durham, North CarolinaBiostatistician @ Children's National Health System Responsibilities include:• Design clinical trial and clinical research, review and write the protocol statistical section, calculate the sample size, write and review statistical analysis plan(SAP), review the case report form (CRF).• Write specification for data validation, dataset creation including CDISC(SDTM, AdaM) dataset, table, listing and figure, and specification for statistical programming• Prepare the clinical trial table, listing and graph, analyze the data, prepare the analysis report (such as DSMB report, interim analysis report and final report, FDA annual report, etc), attend meeting representing statistics team • Provide statistical consultation on study design, statistical analysis plan, sample size calculation , data simulation, data analysis and other statistical issues for grant proposal and clinical research • Statistical methodology research in clinical trial and clinical research• PK/PD research for pre-clinical study and clinical trial • Provide supervision, mentorship and training to programmer, lower level and new staff.Major accomplishments include:• As a study biostatistician, I completed more than 10 Phase 1-IV clinical trial in metabolic disease, neurological disease, oncology, and epilepsy.• Consulted 30+ grant proposals and clinical researches on study design, statistical analysis plan, sample size calculation, data simulation, data analysis and other statistical issues • Performed statistical analyses for more than 200 pre-clinical, clinical studies.• Published 30+ scientific manuscripts From August 2005 to May 2016 (10 years 10 months) Washington D.C. Metro AreaR&D Researcher @ Beijing Fourth Pharmaceutical Corporation Responsible for new drug research and development.Developed 4 3-grade new drugs. From August 1992 to December 1994 (2 years 5 months) Beijing City, ChinaPrincipal Biostatistician @ Parexel Virginia, United StatesSr. Biostatistician @ Cytel • Major responsibilities included: o Act as a team lead for deliverable development on assigned projecto Providing statistical support to clinical studies and/or projects as assigned. o Provide the statistical support for EMA RMP, PSUR, PBRER filing and review the filing package.o Support the regulatory filing by reviwing the filing brief book and providing the expolortory analysis for the filingo Participate in the development of study protocols including study design discussions and sample size calculations, review protocol, statistical analysis plan (SAP), case report form (CRF) review. o Develop chinical study SAP, TLG specfication for clincal study report and DMC meetingo Develop clinical study data edit/check plan and specification and review data edit/check report.o Review ADaM datsets and TLGs output and review clinical study report (CSR).o Review manuscript related to chinical studies.o Provide training and guidance to statistical analyst and programmer.Major accomplishments include o Phase 4, a multicenter, multinational, observational study of Fampyra in patients with multiple sclerosiso Phase 2: a multicenter, double-blind, multidose, placebo-controlled, randomized study to evaluate the efficacy and safety of intravenous BIIB093 for patients with brain contusiono Fampyra EMA Periodic Safety Update Report (PSUR), Risk Mnagement Plan(RMP) filingo Fampyra EMA Addendum to Clinical Overview, Addendum to Summary of Clinical Safety filingo Fampyra China, Mexico and SwissMed Filing From July 2017 to August 2020 (3 years 2 months) Cambridge, MA


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In a nutshell

Jianping He's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

4 year(s), 5 month(s)

Jianping He's Willingness to Change Jobs

Unlikely

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