Director, Biostatistics

Director, Biostatistics

The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: 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. 

Key Responsibilities

• Contribute to strategic thinking and Clinical Development Plan (CDP) development.
• Leads large and/or complex late phase clinical development program(s).
• Promote teamwork, quality, and innovation through effective collaboration with program teams. Foster a productive work environment.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials
• Authors the statistical sections of clinical trial protocols and statistical analysis plans
• Reviews and approves stratification/randomization schema
• 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 ADaM and ad hoc analysis specifications
• Interprets and communicates the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Leads biostatistics support for worldwide regulatory submissions
• Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
• Contributes to scientific articles, summarizing data collected in Alnylam trials
• Consults 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 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

• Experience with Bayesian and adaptive clinical trial design
• Experience leading or supporting NDA and MAA submission
• Proficiency in SAS and R programming language
• Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities

#LI-AB1 #LI-Hybrid

U.S. Pay Range

$212,500.00 - $287,500.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflec