上海招聘

Job Purpose and Key Responsibilities:

¨ Taking a lead role in statistical design of protocol, data analysis , result interpretation and regulatory defense

¨ Making statistical input to drug development strategy in the setting of Therapeutic Matrics Team

¨ Managing external vendors to ensure compliance with GSK SOPs/standards and timely delivery with high quality

Accountability:

¨ Operate in collaboration with study personnel to provide input to study protocol, perform sample size calculation, develop randomization schedule, write/review Reporting Analysis Plan, and write/review Statistical Analysis Report and Clinical Study Report

¨ Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations

¨ Respond to statistical queries from other functional areas (eg medical, regulatory, and marketing) and to interact with regulators as required.

¨ Collaborate with data management in the planning and implementation of data quality assurance plans.

¨ Provide tailored statistics education to less experienced statisticians or other groups if required

¨ Participate in peer-review of work products from other statistical colleagues.

¨ Oversee the process and quality of statistical work contracted out to a CRO or research collaborator

¨ Perform statistical programming if required

Complexity:

¨ Positive working attitude and excellence in self-motivation

¨ Strong learning skill and comfortable to adapt to changes

¨ Ability to negotiate and strategically influence other team members

Specialised Knowledge:

¨ Knowledge of diseases and drug development process

¨ Knowledge of statistical theories and application

¨ Knowledge of clinical trial design elements and potential issues

¨ Knowledge of statistical application tools and IT technique

Basic Requirements:

¨ Educated to Ph.D or master degree in Statistics, Math or equivalent field of study

¨ At least 5 years experience at a multinational pharmaceutical company or international Clinical Research Organization (CRO) as a biostatistician

Preferred Requirements:

¨ Application of advanced statistical theory and techniques in clinical development

¨ Self-management skills with focus on deliverables

¨ Rich knowledge of CDISC and SAS programming