Associate Director, Biostatistics

Role Summary

Associate Director, Biostatistics at BeOne. BeOne seeks experienced, motivated, collaborative professionals who are passionate about fighting cancer. Work with cross-functional study teams supporting hematology studies and provide statistical support in designing and analyzing clinical trials, coordinating statistical activities for clinical projects, and contributing to manuscripts and health authority submissions.

Responsibilities

• Develop or assist in the development of study protocols and SAPs and determine appropriate statistical methodologies for data analysis.
• Participate in database design meetings to ensure data quality and that analysis requirements are satisfied.
• Collaborate with statistical programming staff to ensure programs meet analysis requirements, SOPs, and regulatory requirements.
• Analyze data and interpret results from clinical trials to meet study objectives; apply basic and complex techniques under supervision.
• Prepare oral and written reports to communicate results to the project team.
• Provide responses to queries related to study design, analysis, and interpretation from clinical monitors, regulatory agencies, and investigators.
• Engage in research activities for innovative statistical methods and applications in clinical trial development.

Qualifications

• Experience with clinical trials and knowledge of regulatory guidance is required.
• Oncology experience is preferred but not required.
• Strong written and oral communication skills and ability to work within a team and independently.
• Analytic thinking, ability to build strategic working relationships, and good decision-making capability.

Education

• PhD in Statistics or related field with 4+ years of experience in clinical drug development required.
• Knowledge of SAS and/or R is strongly desirable.

Skills

• Statistical analysis and study design
• Data management and interpretation of clinical trial results
• Communication of complex statistical concepts to non-statisticians
• Collaborative work with cross-functional teams

Additional Requirements

• Travel: Not required