（资深）生物统计师（北京/上海）

Responsibilities 该职位来源于猎聘 We are looking for (Senior) Biostatistician. As a (Senior) Biostatistician, you are responsible for providing statistical services on Phase I-IV clinical trials, including but not limited to the responsibilities below:

Assist with protocol development, sample size calculation, protocol and case report form (CRF) review

• Advise data management staff on database design, and be responsible for critical data and data quality review
• Prepare randomization specifications; generate schedules; verify randomization components (specification and schedule)
• Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data–handling rules and mockups

SAS programming and related activities for the presentation and analysis of clinical trial data

Provide support for special committees, e.g., DMCs including input/review of charters and maintenance of appropriate blinding

Responsible for statistical input to statistical reports and Clinical Study Reports

Understand the submission issues, having the ability to communicate with experts in CDE in an effective manner

Interact with clients as key contact with regard to statistical and contractual issues

Provide consulting services in statistical field, which includes but not limited to study design interpretation, problem-solving in implementation, data-examination guidance and research-result explanation

Education/Qualifications : PhD or Master in statistics/biostatistics, mathematics, epidemiology, or other related data science majors

Good communication skills and ability in building sound relationships

Good collaboration with colleagues, working in a high efficient and cross-functional manner

Knowledge of relevant internal and external standards and guidance for clinical development (CDISC, EMEA/FDA, ICH-GCP etc.)

A good understanding of statistical issues in clinical trials

Understand and apply moderately advanced statistical methods

Ability to work independently