Associate Director, Biostatistics

Role Summary

BeOne is seeking an experienced biostatistics professional for the Associate Director, Biostatistics role. The candidate will work with cross-functional study teams supporting hematology studies, review data, and develop and implement the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. The role also involves providing content for manuscripts and presentations and offering statistical support in designing and analyzing clinical trials, coordinating statistical activities across clinical projects.

Responsibilities

• 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 of high quality and satisfy analysis requirements.
• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal SOPs, and external regulatory requirements.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol, applying basic and advanced 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 investigators.
• Engaged in research activities for innovative statistical methods and applications in clinical trial development.

Qualifications

• Required: Experiences with clinical trials and knowledge of regulatory guidance.
• Preferred: Oncology experience.
• Required: Demonstrated written and oral communication skills and ability to work within a team and independently.
• Required: Interdependent/analytic thinking skills, building strategic working relationships, and good decision-making capability.

Education

• A minimum of a PhD in Statistics or related field with 4+ years of experience in clinical drug development is required.

Skills

• Knowledge of SAS and/or R is strongly desirable.

Additional Requirements

• Travel: Not required