Principal Biostatistician
Posted on 9/15/2023
Denali Therapeutics

201-500 employees

Develops therapies for neurodegenerative diseases
Company Overview
Denali Therapeutics stands out as a leader in the field of neurodegenerative diseases, leveraging recent scientific insights into genetic causes and biological processes to develop effective treatments for conditions like Alzheimer's, Parkinson's, and ALS. The company's culture is characterized by a commitment to rigorous science, translational medicine, and collaboration, fostering an environment where diverse backgrounds and experiences unite behind the shared goal of defeating degeneration. Denali's competitive advantage lies in its deep expertise in neurodegenerative disease biology and the blood-brain barrier, which informs a robust portfolio of programs at various stages of clinical and preclinical development, all aimed at improving patient lives by addressing disease causes or risk factors.

Company Stage


Total Funding





South San Francisco, California

Growth & Insights

6 month growth


1 year growth


2 year growth

San Bruno, CA, USA
Experience Level
Desired Skills
Biology & Biotech
  • PhD. in Statistics or Biostatistics with a minimum of 5 years clinical development experience in multiple programs
  • Extensive knowledge of statistical methodology and its application to solve problems in the pharmaceuticals/biotechnology setting
  • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
  • Strong analytical and problem-solving skills; expert collaboration and communication skills
  • Experience working with orphan indications highly desired
  • Strong programming skills in R, Shiny, Markdown; working knowledge of Git and Unix/Linux environments
  • Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
  • Ability and interest to work cross functionally
  • Highly independent, curious and creative, can do attitude, and embraces continuous improvement culture
  • Devise and lead statistical strategies for clinical development of drug candidates including pivotal Phase 2/3 studies and NDA/MAA/BLA submissions
  • Ensure statistical integrity of analysis and reporting deliverables, including guidance on statistical methodology, optimization of study designs, endpoint selection, author/review statistical sections of the protocol, clinical study reports and related documents, oversee timelines and study level tasks pertaining to statistical analysis and reporting
  • Conduct hands-on exploratory analyses, sample size estimation, modeling and simulation, and create tools to gain useful insights from data as needed
  • Consult on methodologies for modeling large scale data (e.g., metabolomics, genetic)
  • Interpret, summarize and present data and statistical considerations to internal project teams, senior management, advisory board meetings and to global health authorities
  • Collaborate with Clinical Operations to select, oversee, contract, and manage Biostatistics vendors and contract research organizations
  • Teach Stats basics and/or create standard tools and practices to enable colleagues to visualize and gain insights from their data
  • Seek out interesting problems and use Statistics to solve them