Associate Director, Biostatistics

For one or more products within related Therapeutic area, responsible for all statistical aspects of clinical development plan, individual studies and submissions, including quality, relevance to regulatory perspective and scientific validity, in collaboration with clinical and regulatory leads.

Responsibilities

• Provides input into product development strategy by suggesting innovative designs and decision making tools. 
• Selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; Reviews protocols.
• Oversees execution of statistical analyses, reviews statistical outputs and guarantees results interpretation. 
• Reviews and approves the statistical methods and results sections for clinical study reports (CSR).
• Reviews regulatory documents such as CSRs, as well as integrated reports and summary documents. 
• Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
• Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions.  
• Oversees statistical support to multiple project teams.
• Works independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project. 

Requirements & Experience

• Provides input into product development strategy by suggesting innovative designs and decision making tools. 
• Selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; Reviews protocols.
• Oversees execution of statistical analyses, reviews statistical outputs and guarantees results interpretation. 
• Reviews and approves the statistical methods and results sections for clinical study reports (CSR).
• Reviews regulatory documents such as CSRs, as well as integrated reports and summary documents. 
• Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
• Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings. Completed data package relevant for submission or making key decisions.  
• Oversees statistical support to multiple project teams.
• Works independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.