Associate Director, Biostatistics

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September 26

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BeOne Medicines

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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.

10,000+ employees

Founded 2010

📋 Description

• Work with cross-functional study/project teams supporting hematology studies • Interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists • Review the data, develop and implement the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents • Provide content for manuscripts / presentations • Provide statistical support in designing and analyzing clinical trials • Coordinate the statistical activities for clinical projects • Develops or assists development of study protocols and SAPs and determines appropriate statistical methodology for data analysis • Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements • Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements • Analyzes data and interprets results from clinical trials to meet objectives of the study protocol • Applies and implements basic and complex techniques to these analyses under supervision • Prepares oral and written reports to effectively communicate results of clinical trials to the project team • Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators • 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 • 4+ years of experience in clinical drug development • Experiences with clinical trials and knowledge of regulatory guidance • Knowledge of SAS and/or R is strongly desirable • Demonstrated written and oral communication skills • Ability to work within a team and work independently • Interdependent/analytic thinking skills • Building strategic working relationships • Good decision-making capability

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness • Annual bonus plan (for Non-Commercial roles) • Incentive compensation plan (for Commercial roles) • Discretionary equity awards • Employee Stock Purchase Plan