Statistical Trial Design and Analysis

• Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
• Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
• Collaborate with data management in the planning and implementation of data quality assurance plans.
• Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
• Participate in peer-review work products from other statistical colleagues.
• Utilize deep technical skills to drive solutions to complex design and analysis issues.

Communication of Results and Inferences

• Collaborate with team members to write reports and communicate results.
• Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
• Respond to regulatory queries and to interact with regulators.

Therapeutic Area Knowledge

• Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
• Integrate deep statistical, therapeutic and regulatory expertise into the development and commercialization strategies

Regulatory Compliance

• Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training

M.S. with equivalent experience
Statistics, Biostatistics, or equivalent of field study

亚洲/太平洋地区

中国

上海

2020-08-21