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Position Title:Statistical Analysis Manager
Department:Biostatistics & Programming
Location:Shanghai

Position Summary

Sophisticated programming support for projects, and develop SAS macros for projects and global library. May lead project team to provide client support, lead and manage projects.

Key Responsibilities

  • Act in the key role for oversight of project process, resource, timeline, such as providing estimation and forecast, make business presentation 
  • Interact with multi-disciplinary teams to identify critical needs and develop strategic initiatives, or process / technology enhancement 
  • Communicate with sponsors and internal functions as the key contact on statistical programming issues and projects. 
  • Conduct hands-on statistical analysis tasks, including map, derive and validate tabulation datasets and analysis datasets, generate TLFs; develop mapping specs for tabulation datasets and analysis datasets; annotate CRF (SDTM variables); prepare submission package; develop TLFs programming specs; develop macro; generate Randomization schema, etc. 
  • Develop and Maintain central macro library 
  • For team leader, train new staffs and/or Lead team, including recruit, mentoring new staff 
  • Provide CDISC Implementation and programming Process consultation 
  • Develop into go-to person for one or more therapeutic areas

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Bachelor degree or above in biostatistics, statistics, mathematics, computer science, pharmacy or related scientific disciplines; or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology; Master will be a plus.
  • No less than 5 years statistical programming and analysis experience in biopharmaceutical or CRO companies; Including at least 3 years solid experience in project management

  • Key Competency Requirement

  • Extensive knowledge in GCP/ICH guidelines 
  • High proficiency in SAS skills; Other programming skills will be a plus, such as SQL, VB/Other computer language, C#, XMLSolid experience in Relational Database 
  • Extensive knowledge in CDISC CDASH/SDTM/ADaM data standard; CDISC ODM, define.XML and other data standards 
  • Strong communication in Chinese and English, written and verbal; Effective presentation skills in broad audiences 
  • Effective interpersonal skills and a team player 
  • Solid project management and resource planning skills to plan, organize and prioritize work, project schedule and team workload 
  • Demonstrate self-initiative and customer service focused 
  • Demonstrate thought process and skills to identify issues and resolve problems 
  • Good influence to others 
  • Demonstrate business and organization acumen 
  • For team leader, develop and engage team members to build a positive work relationship
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