职位详情
五险一金
带薪年假
节日礼物
团队聚餐
领导好
公司规模大
扁平管理
职责描述:
Key Accountabilities :
Assume the ability to meet the requirements of a Biostatistician I with a high degree of proficiency and autonomy
Deliver best value and high quality service Ensure quality control (QC) on all process and technical activities related to: o trial set-up and maintenance, and/or o derived dataset, table, listing, and figure programming and/or
In accordance with corporate quality standards, SOPs/Working Instructions, ICH-GCP and/or other international regulatory requirements are performed.
Maintain all supporting documentation for studies in accordance with SOPs/Working Instructions to ensure traceability and regulatory compliance.
Proactively participate in quality improvement initiatives.
Ensure compliance with SOPs/Working Instructions, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required Use efficient programming techniques to produce and/or QC low-medium complexity derived datasets, tables, figures and data listings.
Production and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques.
Understand and apply moderately advanced statistical methods.
Coordinate and lead a project team to successful completion of a project within given timelines and budget.
Interact with clients as key contact with regard to statistical and contractual issues.
Check own work in an ongoing way to ensure first-time quality.
Proactively participate in and/or lead process/quality improvement initiatives.
Mentor and train junior members of the department.
Additional responsibilities as defined by supervisor/manager.
Prepare statistical data for inclusion in reports to Data Monitoring Committee (DMC), regulatory agencies, managers, or clients.
任职要求:
任职要求:
Skills :
Proficiency in SAS programming, software SPSS, and R, etc
Knowledge of the programming and reporting process within DO
Knowledge of SOPs/Working Instructions /System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change Business/Operational skills that include customer focus, commitment to quality management and problem solving
Work effectively in a quality-focused environment
Effective time management in order to meet daily metrics or team objectives
Shows commitment to and performs consistently high quality work
Education :
First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience
Language Skills :Competent in written and oral English
其他信息
语言要求:英语、普通话