Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Shanghai

Description

Clinical Development
Operates at the Global Development Team level, either as Project Lead Statistician or as the sole representative for Biostatisticians, Epidemiologists, Patient Reported Outcomes scientists, statistical programmers, and clinical data managers on a Global Development Team
Provides statistical leadership for clinical development projects, including providing strategic input into clinical development plans and target product profiles
Directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies within the project, including activities to support personal healthcare strategy and governance committee decision making
Provides analytical and strategic leadership for exploratory activities such as personalized healthcare biomarker development and PK/PD modelling
May serve as lead statistician for one or more study management teams, with the incumbent responsibilities and accountabilities
Leads cross-functional teams in overseeing the generation of health authority submission datasets and associated documentation
Company Biostatistics lead for Health Authority interactions
Oversees the deliverables from Statistical CROs
Serves as member of business development due diligence efforts
Proactively advises teams and functions on overall data strategy and the best application of statistical methods including advanced analytics to any data type
Nonclinical Statistics
Provides statistical leadership to nonclinical projects
Directly responsible for the statistical integrity, adequacy, and accuracy of nonclinical studies  
Serves as expert statistical consultant for nonclinical projects and drives the development of new statistics courses
Establishes new technical directions and collaborations within assigned area of focus
Functional Area
Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, etc.
Leads Biostatistics and cross-functional initiatives
Leads the development of functional processes
Recognized expertise in clinical trials and statistical methodology for a clinical indication and/or statistical methodology for specialized applications
People Development and Management
Mentors statisticians on request
Technical Requirements
MSc or PhD in Statistics, Biostatistics, Mathematics or similar areas of academic discipline
Good knowledge of English in a business environment  
Experience in using statistical software

About the company

Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.

The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.

Companies in this sector

Hives where you can find this job offer