Position Title:Statistical Analysis Senior Manager
Department:Biostatistics & Programming

Position Summary

Lead team or act as subject matter expert in project management and delivery. Lead the continuous enhancement of process, tools, technology, and service level to provide better customer support. Take accountability to train and develop best-in-class statistical analysis team.

Key Responsibilities

  • Lead team for high quality project delivery, and be accountable for project and resource oversight 
  • Responsible for project leadership, resource management and forecast, timeline and activity tracking. 
  • Take initiative to collaborate with multi-disciplinary teams to identify critical needs and develop strategic initiatives, or process/technology enhancement 
  • Act as key contact in communication with sponsors and internal functions related to statistical programming activities. 
  • Support business development opportunities and attending business meetings as needed 
  • Work as an expert to provide CDISC implementation or programming process consultation. 
  • Act in the key role in SOP and Working Instruction development, review and implementation 
  • Develop and maintain tools or central macro library to continuously enhance efficiency and effectiveness. 
  • Play team leadership role to train, coach and develop team members 
  • Support routine operational work, such as mapping, deriving and validating datasets, conducting quality control measures, providing support to submission package preparation, etc.

  • 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 desired. 
  • No less than 7 years statistical programming and analysis experience in biopharmaceutical or CRO companies; Including at least 5 years' solid experience in project management

  • Key Competency Requirement

  • Extensive knowledge and experience in GCP/ICH guidelines 
  • Expertise in SAS skills; Other programming skills will be a plus, such as SQL, VB, C#, XML, or other computer languages 
  • Extensive experience in Relational Database Expertise in CDISC CDASH/SDTM/ADaM data standard, CDISC ODM, define.XML and other data standards 
  • Excellent communication in Chinese and English, written and verbal; Effective presentation skills in broad audiences 
  • Effective team leadership and interpersonal skills 
  • Extensive project management and resource planning experience to plan, organize and prioritize work, project schedule and team workload
  • Self-initiative and customer service focused 
  • Demonstrate strong thought process and innovative approach to identify issues and resolve problems 
  • Strong influence skills to key stakeholders and various groups of people 
  • Demonstrate business and organization acumen 
  • Strong capability in developing team members and maintain an engaged team 
  • Exposure in industry or technical events and forums
  • Apply for the position

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