Associate Director, Biostatistics

Role Summary

Lead biostatistics activities for hematology clinical studies, collaborating with cross-functional study teams to review data and develop and implement the statistical analysis plan (SAP) for the clinical study report (CSR) and other regulatory submissions. Provide statistical support in designing and analyzing clinical trials, contribute to manuscripts and presentations, and coordinate 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 complex techniques 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.
• Involved 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.

Skills

• Analytical thinking and data analysis
• Communication (written and oral)
• Team collaboration and ability to work independently

Education

• Required: PhD in Statistics or related field with 4+ years of experience in clinical drug development.
• Preferred: Knowledge of SAS and/or R.

Additional Requirements

• Travel: Not required