中文

Position Title:Statistical Analysis Manager
Department:Biostatistics & Programming
Location:Shanghai
Position Summary
  1. Per project needs, analyzes the requirements, writes SAS programs to generate results and makes sure the results are correct and meets the requirements;
  2. Develop SAS macros for projects and global library;
  3. May lead project team to complete the tasks as listed;
  4. Manage clients, projects, and staff;
  5. Support to maintains SOPs.

Key Responsibilities

  • Map/derives tabulation datasets and analysis datasets, generate TLFs.
  • Validate tabulation datasets, analysis datasets, and TLFs.
  • Develop mapping specs for tabulation datasets and analysis datasets
  • Annotate CRF (SDTM variables)
  • Prepare submission package
  • Develop TLFs programming specs
  • Develop macro per project needs
  • Generate Randomization schema
  • Manage project resources/timeline/budgets
  • Communicate with sponsors as the key contact on statistical programming issues.
  • Communicate with DMs and Statisticians on programming related items.
  • Oversight project process, ensure that SOPs/WIs are followed.
  • Develop/Maintain central macro library
  • For team leader, train new staffs and / or Lead team, including recruit, mentor new staff
  • Maintain SOPs/WIs
  • Optimize the working process
  • Lead or support enhanced or new solutions to meet business need
  • Coordinate the development and implementation of Standard Operating Procedures and
  • Working Instructions Documents.
  • Interact extensively with a multi-disciplinary senior management team to identify critical needs
  • and develop strategic initiatives, or process / technology enhancement
  • Provide estimation and forecast on Tasks/Time
  • Make business presentation per request
  • 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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China:
298 Xiangke Road, 3/F, 301-305, Zhangjiang Hi-Tech Park, Pudong, Shanghai 201210, China
Tel: +86 21 5090 0085 Fax: +86 21 6875 5515
US:
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Phone: +1-212-681-2100
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