Principal, Biostatistician

Denali Therapeutics•South San Francisco, CA

2d•$171,000 - $223,000

About The Position

This role shapes the statistical strategy that carries Denali's clinical programs from first-in-human studies through pivotal registration trials. It applies deep scientific judgment to problems with significant ambiguity, working with intangible variables that affect development timelines and regulatory outcomes. The role builds Denali's emerging reputation in biostatistics by driving intangible-variable analysis, mentoring statistical staff, and representing the function in interactions with regulators, vendors, and cross-functional leadership.

Requirements

Typically requires a Ph.D. in Statistics, Biostatistics, or a related discipline with 6+ years of relevant experience including responsibility for study level strategy and decision making or a Master's degree in a related discipline with equivalent related experience.
Typically requires late-stage (Phase 3) clinical trial planning, conduct, and reporting experience.
Strong programming proficiency in R and Markdown/Quarto; working knowledge of git and Unix/Linux environments.
Working knowledge of CDISC, SDTM, and ADaM data standards.
Demonstrated ability to lead cross-functional teams and influence senior stakeholders without direct authority.

Responsibilities

Design and lead statistical strategy across the full clinical development lifecycle, from first-in-human through pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
Leads development of key clinical study deliverables, including statistical analysis plans, protocol statistical sections, and clinical study reports.
Exercise independent judgment in selecting and adapting statistical methods where standard approaches don't fully apply.
Own the statistical integrity and accuracy of analysis and reporting deliverables against SOPs and regulatory requirements.
Lead exploratory analyses, sample size estimation, and modeling/simulation to generate insight from ambiguous or incomplete data.
Present statistical strategy and findings to senior management and influence cross-functional decision-making.
Oversee and mentor other biostatisticians, providing technical direction without formal people-management authority.
Manage and provide oversight of Biostatistics vendors and CROs, including performance and quality of external statistical deliverables.
Maintain expert knowledge of statistical methodology, therapeutic-area drug development, and the evolving regulatory environment.