Senior Manager, Biostatistics

General Description:

The Senior Manager, Biostatistics will perform scientific statistical analyses in support of clinical trials with guidance and mentoring on new and complex issues. The position will work with the clinical and regulatory team in designing clinical trials and developing the statistical analysis plan, facilitate the implementation of statistical analyses, provide statistical input to the CSR and scientific presentations/manuscripts. The individual will interface with clinical therapeutic area members, SAS programming, clinical data management, clinical operation, clinical pharmacology, medical writing and other functions. This position will also participate in managing vendors to ensure quality of all deliverables and adherence to requirements/timeline. This position needs knowledge of clinical trial design concepts, in-depth knowledge of all phases of the drug development process and demonstrated skills in the planning, analysis and reporting of clinical trials.

Essential Functions of the job:

· Responsibilities will include, but are not limited to, the following:

· Serve as trial statistician and work in the cross-functional team for study planning and execution, and reporting.

· Develop individual protocol/SAP and determine appropriate statistical methodology.

· Participate in database design meetings to ensure that the data collected are in high quality and satisfy analysis requirements.

· Collaborate with the statistical programming staff to ensure that all programs meet analysis and external requirements. Work with programmers to provide tables, listings and graphs, including ad hoc validation.

· Analyze data and interpret results from clinical trials to meet objective of the study protocol. Independently apply and implement basic and complex statistical techniques to these analyses. Conduct ad hoc analyses if applicable

· Prepare oral and written reports to effectively communicate results of clinical trials to the project team and corresponding parties.

· Provide statistical input through the planning and conduct of clinical trials with departments with BeiGene as well as with external vendor.

· Make recommendations or resolve technical, quality, and timeline issues.

· Participate in innovative statistical methodology development that stemmed from project questions.

· Provides stat support in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests.

· Identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of studies, proposes solutions and carries them out.

· Serves as statistical representative in the cross-functional teams for all the project involved.

Supervisory Responsibilities:

· No

Education Required:

PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3+ years relevant work experience

Master’s degree with a minimum of 5+ years relevant work experience

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.