Associate Director, Biostatistics

The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

This is a hybrid position, based two days a week onsite at our offices in Maidenhead.

Summary Of Key Responsibilities

• Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
• Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• Contributes to or prepares statistical analysis plans.
• Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs.
• Provides statistical guidance on conduct of ongoing trials.
• Collaborates with Statistical Programmers on summary and analysis of trial data.
• Writes ADS and ad hoc analysis specifications.
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
• Contributes to scientific articles, summarizing data collected in Alnylam trials.
• Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
• Consults with Research & Preclinical colleagues on statistical questions in their work.
• Manages CRO statistical and programming support.