Associate Director, Biostatistics

Overview

In this role you drive statistical activities for clinical trials, shaping trial designs, statistical sections of protocols, and analysis plans. You collaborate across Clinical Development, Regulatory, and Operations to support medicine development and regulatory submissions. You provide statistical guidance on ongoing trials and represent the company in regulatory and stakeholder meetings. You lead statistical collaboration with CROs and contribute to study reports and publications with a patient-focused impact.

Responsibilities

• Represent biostatistics in cross-functional development teams to shape clinical plans
• Collaborate acrossClinical Development, Regulatory and Clinical Operations to design trials
• Write statistical sections of protocols and consult with experts
• Prepare or contribute to statistical analysis plans
• Design eCRFs with Data Management and Clinical Operations
• Provide statistical guidance on ongoing trials
• Collaborate with Statistical Programmers on data summaries and analyses
• Write analysis specifications and ADS
• Contribute to clinical study reports and regulatory documents (DSURs, Briefing Documents)
• Represent Alnylam in regulator and external stakeholder meetings
• Contribute to scientific articles summarizing trial data
• Support Biostatistics and Development Team in various activities
• Consult with Research & Preclinical on statistical questions
• Manage CRO statistical and programming support

Key requirements

• Ph.D. in Biostatistics or Statistics or equivalent with ≥7 years pharma biostatistics experience or MS with ≥10 years relevant experience
• Excellent written and oral communication and presentation skills
• Experience programming in SAS
• Interest in and basic understanding of biology and RNAi

• strong communication
• cross-functional collaboration
• stakeholder engagement
• SAS programming
• R programming
• EAST

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