Biometrics Associate Director / Director

Department
部门

Quantitative Sciences
Title
职位
Associate Director / Director, Biostatistics
Starting Date
任职时间
Direct Report
直线经理
Yonggang Zhao, Global Head of Quantitative Sciences
Direct Subordinates
直接下属
Manager / Sr Manager, Biostatistics
Primary Function
主要职能

Serve as the biostatistics lead to be responsible for China portfolio studies.

Major Responsibilities and Duties
主要职责和任务
  • Provide biostatistics leadership/support for China portfolios which include guidance on statistical methods, appropriate study design and interpretation of results and strategic input into clinical development planning.
  • Contribute to developing company SOPs, process and practice.
  • Mentor and develop talents.
  • Collaborate effectively with Clinical Development colleagues by driving statistical thinking, quantitative decision making, proper data interpretation and disciplined exploratory data analysis.
  • Develop clinical development plan, clinical protocols, statistical analysis plans (SAPs).
  • Define and lead the analysis of relevant internal and external information to inform design decisions.
  • Be responsible for statistical content and data interpretation for Clinical Study Reports (CSRs), publications/presentations and/or regulatory documents.
  • Perform other statistical analyses duties as needed.
  • Help to develop and maintain I-Mab Lifecycle Data Standards.
  • Oversee CROs regarding statistical and programming activities to ensure compliance, quality and timely delivery.
Qualifications
资格要求
  • Education: MS or PhD in biostatistics, statistics or related field is required.
  • Experience: a minimum of 5 years (or 8 years for director) of relevant experience including lead statistician role at compound level within pharmaceutical or biotechnology industry is required. Oncology experience is highly desired.
  • Comprehensive knowledge of advanced statistical methods and applications in study design and analysis.
  • Ability to implement innovative and advanced study designs, particularly in early phase oncology studies.
  • Ability to communicate with clarity and influence in English and Chinese.
  • Proficient SAS and/or R programming skills, solid understanding of CDISC standards.
  • Knowledge of NMPA/ICH/FDA/EMA guidelines.
  • Demonstrated ability to serve effectively as a delivery team leader.
  • Ability to manage and mentor project/study statisticians.
  • Ability to effectively collaborate and influence throughout multiple levels of the organization.