Alnylam Pharmaceuticals · 2 days ago
Associate Director, Biostatistics
Alnylam Pharmaceuticals is a leader in RNAi therapeutics, focusing on innovative approaches to treat diseases. The Associate Director, Biostatistics will oversee statistical activities for clinical trials, including trial designs and analysis of clinical data, while collaborating with various teams to ensure successful clinical development.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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
Qualification
Required
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
Preferred
Experience in clinical development through Phase 3 (NDA submission)
Experience as lead statistician for a compound
Understanding of ICH GCP as well as general knowledge of industry practices and standards
Proficiency in R programming language and other statistical software, including EAST
Experience with CDISC, including SDTM, ADaM, CDASH
Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities
Experience designing and conducting adaptive trials
Benefits
Medical, dental, and vision coverage
Life and disability insurance
A 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.
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
Recent News
2025-12-22
2025-12-20
Company data provided by crunchbase