Associate Director, Biostatistics

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.