Associate Director, Biostatistics

🕒 April 26

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BeOne Medicines

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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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