Alnylam Pharmaceuticals · 1 week ago
Director, Biostatistics
Cambridge, MA
Full-time
Onsite
Director/Executive
$207K/yr - $280K/yr
8+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, focused on transforming the lives of people with rare and common diseases. The Director of Biostatistics will lead complex late-phase clinical development programs, collaborate with various teams to design innovative clinical trials, and provide statistical guidance throughout the clinical trial process.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
Lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase