Associate Director, Biostatistics

General Description:

Work with cross-functional study/project teams supporting hematology studies and interact with Clinical, Regulatory, Statistical Programming, Data Management and other Research Scientists in reviewing the data, developing and implementing the statistical analysis plan (SAP) for the clinical study report (CSR) and other health authority submission documents. Provides content for manuscripts / presentations and provides statistical support in designing and analyzing clinical trials, and in coordinating 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.

Knowledge of SAS and/or R is strongly desirable

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.

Not required

A minimum of a PhD in Statistics or related field with 5+ years of experience, or a Master’s degree with a minimum of 8 years of experience in clinical drug development is required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.