Buy/Sell/RentServicesReal EstateEventsShanghai JobsBusinesses
Fonolive, #1 Social Job Search Engine Create your resume profile in just 5mins.
Biostastics Head Shanghai Proclinical Shanghai

Biostastics Head Shanghai

Proclinical
Shanghai
2020-11-17 17:11:43
Biostastics Head Shanghai
An international pharmaceutical company is advertising a vacancy for a Biostatistician Head, based in Shanghai. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.

Job Responsibilities
• Provide sound experimental design and data analysis expertise.
• Author the protocol statistical sections and generate statistical analysis plans and study randomization as needed.
• Review and sign off on relevant study documents and data management and programming deliverables.
• Prepare and review mockup tables, figures, and listings (TLFs); determine analysis and data presentation specifications for CRO programmers and statisticians.
• Partner with Medical Affairs and Commercial to provide statistical support for publications (Posters, Manuscripts etc.).
• Manage the CROs performing analysis; interpret study results and collaborate with medical and biostatistics staff to produce safety monitoring reports... interim and final reports, and publications.
• Represent the statistical function on project teams and in cross functional meetings.
• Supervise and lead the biometrics function to respond to all statistical needs.
• Work closely with medical, clinical sciences, clinical development operations, regulatory, research, project management, drug safety, and business development to optimize the design and conduct of studies, to generate data, to facilitate our interactions with regulatory agencies, business partners, presentations at scientific congresses and final manuscripts.

Skills and Requirements:
• D. in biostatistics, statistics, or a closely related field.
• Fluent in Chinese, native speaker preferred. Good command of English.
• 10+ years of experience in the support of clinical studies management and/or related work experience in a biotechnology or pharmaceutical company, or similar environment (e.g., CRO).
• 6+ years managing people.
• Must possess a comprehensive and detailed understanding of statistical experimental design and analysis, clinical trial requirements and statistical software packages such as SAS.
• Understanding of regulatory guidelines that affect statistical deliverables.
• Experience in immunology, hematology, and or oncology studies preferred.
• Experience with NDA and BLA submissions that a must including ISS, ISE development.
• Experience with regulatory interactions (FDA or EMA or NMPA).

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-LW1
Shanghai China
Biostastics Head Shanghai Proclinical Shanghai
Meet locals, buy, sell, find deals, real estate, events on the #1 social classifieds.

Popular Fonolive Groups

Coronavirus - Questions and Answers New York City NY United States
Coronavirus - Questions and Answers (174 members)
New York City NY United States
Black Lives Matter - Making History New York City NY United States
Black Lives Matter - Making History (172 members)
New York City NY United States
Ambazonians Fight For Freedom New York NY United States
Ambazonians Fight For Freedom (92 members)
New York NY United States


Copyrights © 2020 Fonolive. All Rights Reserved.