Director, Biostatistics

About the role

The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). Responsibilities include designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions.

Responsibilities

• Contribute to strategic thinking and Clinical Development Plan (CDP) development.
• Lead large and/or complex late phase clinical development program(s).
• Promote teamwork, quality, and innovation through effective collaboration with program teams.
• Collaborate with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials.
• Author the statistical sections of clinical trial protocols and statistical analysis plans.
• Review and approve stratification/randomization schema.
• Collaborate with Data Management, Clinical Development and Clinical Operations on design of eCRFs.
• Provide statistical guidance on conduct of ongoing trials.
• Collaborate with Statistical Programmers on summary and analysis of trial data.
• Write ADaM and ad hoc analysis specifications.
• Interpret and communicate the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts.
• Contribute to clinical study reports and other regulatory documents (e.g., DSURs, Briefing Documents).
• Lead biostatistics support for worldwide regulatory submissions.
• Represent Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders.
• Contribute to scientific articles summarizing data collected in Alnylam trials.
• Consult with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial colleagues on statistical questions in their work.
• Responsible for timeline management across their clinical development program.

Qualifications

• Ph.D. in Statistics or Biostatistics or equivalent with at least 8–10 years of pharmaceutical statistics experience (preferred).
• Excellent written and oral communication and presentation skills.
• Experience designing and supporting late-phase (Phase 2/3) clinical studies.
• Experience conducting clinical trial simulations to evaluate design options, operating characteristics, and decision criteria.
• Interest in and basic understanding of biology and biological processes, including RNAi.
• Experience with Bayesian and adaptive clinical trial design.
• Experience leading or supporting NDA and MAA submissions.
• Proficiency in SAS and R programming languages.
• Experience representing sponsors in meetings with US FDA and international regulatory authorities.

Pay

U.S. Pay Range: $212,500.00 – $287,500.00