San Mateo, CA, 94497, USA
4 days ago
Associate Director, Statistics
**Purpose of Job** Develops, coordinates, and provides statistical leadership and support for BeiGene’s drug development in a Therapeutic Area or indication area. Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other BeiGene Research Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical projects. May interact with Contract Research Organization (CRO). This position may serve as statistical lead in one compound and people manager . **Major Responsibilities** Develops and reviews individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis. Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses. Prepares and review oral and written reports to effectively communicate results of clinical trials to the project team, Management team, regulatory agencies, or investigators. Independently provides and reviews responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. Independently involved/provides guidance to direct reports in research activities for innovative statistical methods and applications in clinical trial development. Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for compound development Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out. Plans and ensures the accuracy of Statistical Review Aids submitted to regulatory agencies as author and reviewer Is independently involved/provides guidance to direct reports in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs under management supervision Mentors and guides junior staff in functional activities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Confirm your E-mail: Send Email