Associate Director, Biostatistics

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General Description:

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• The position will work with the Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists 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.

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. The position can be remote, with preference for the selected candidate to be near one of the BeOne offices in California, Massachusetts, Maryland, or New Jersey.

• Essential Duties & Responsibilities:

• + Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development.

+ Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs. + 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. + Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis. + 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 oral and written reports to effectively communicate results of clinical trials to the project team, Management team, regulatory agencies, or individual investigators. + Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. + Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies. + Involved in research activities for innovative statistical methods and applications in clinical trial development.

• Computer Skills:

• Knowledge of SAS and/or R is strongly desirable

• Education Required:

• A minimum of a PhD in Statistics or related field with 4+ years of experience, or a Master's degree with a minimum of 6+ years of experience in clinical drug development is required.

• Other Qualifications:

• Experiences with clinical trials and knowledge of regulatory guidance are required.

Oncology experience is preferred but not required. Demonstrated written and oral communication skills and ability to work within a team and work independently are required. Other important requirements include interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.

• Travel:

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