Associate Director, Biostatistics
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Job Description
Associate Director of Biostatistics managing statistical analysis plans for clinical trials at BeOne, a global oncology company. Collaborating with research scientists to ensure successful clinical development and execution.
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.
Requirements:
- 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.
- 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.
Benefits:
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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