Senior Biostatistics Lead, Clinical Trials Strategy

Alnylam Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid time off

Wellness days

Recharge breaks

Job summary

Alnylam Pharmaceuticals is seeking an Associate Director of Biostatistics to lead statistical activities for clinical trials, contribute to trial design, and author statistical sections of protocols and SAPs. The role includes collaboration with cross-functional teams, CRO management, and regulatory interactions to ensure robust analysis and regulatory-grade documents.

The ideal candidate has a Ph.D. or equivalent with extensive pharma biostatistics experience, strong SAS programming skills, and

Qualifications

• Ph.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience.
• Excellent written and oral communication and presentation skills.
• Experience programming in SAS.
• Interest in and basic understanding of biology and biological processes, including RNAi.
• Experience in clinical development through Phase 3 (NDA submission).
• Experience as lead statistician for a compound; knowledge of ICH GCP and industry practices.

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.

Skills

Communication skills

Cross-functional collaboration

Education

Ph.D. in Biostatistics or Statistics or Equivalent

MS in Biostatistics or Statistics

Tools

SAS

R

EAST

CDISC (SDTM, ADaM, CDASH)

Job description

Alnylam Pharmaceuticals is seeking an Associate Director of Biostatistics to lead statistical activities for clinical trials, contribute to trial design, and author statistical sections of protocols and SAPs. The role includes collaboration with cross-functional teams, CRO management, and regulatory interactions to ensure robust analysis and regulatory-grade documents.

The ideal candidate has a Ph.D. or equivalent with extensive pharma biostatistics experience, strong SAS programming skills, and