Principal Biostatistician

**Principal Biostatistician**

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.

**The Opportunity**

**Responsibilities**
- 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.

**Requirements**:

- PhD. in Statistics or Biostatistics with a minimum of 5 years clinical development experience in multiple programs.
- 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.

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