Cambridge, MA | Contract
Duties: The Senior Biostatistician - 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.
Responsibilities: 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 support 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.
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 colleagues on statistical questions in their work. Manages CRO statistical and programming support.