Director, Biostatistics

Alnylam Pharmaceuticals

18h•Hybrid

About The Position

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.

Requirements

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 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

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