Principal Biostatistician — Lead Clinical Statistics & Strategy

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 171,000 - 223,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Broad range of other benefits

Job summary

Denali Therapeutics Inc. seeks a senior biostatistician to design and lead statistical strategy across the full clinical development lifecycle, from first-in-human to pivotal Phase 2/3 trials and NDA/MAA/BLA submissions.

The role requires a Ph.D. in statistics or biostatistics (or an equivalent Master’s with experience) and 6+ years in study-level strategy, with strong R and Markdown/Quarto skills, plus CDISC standards knowledge.

Qualifications

• Ph.D. in Statistics/Biostatistics with 6+ years of study-level strategy experience or Master’s with equivalent experience.
• Late-stage (Phase 3) trial planning, conduct, and reporting experience.
• Proficiency in R and Markdown/Quarto; working knowledge of git and Unix/Linux.
• Familiarity with CDISC, SDTM, and ADaM data standards.
• Ability to lead cross-functional teams and influence senior stakeholders.

Responsibilities

• Design and lead statistical strategy across the full clinical development lifecycle.
• Develop statistical study deliverables: SAPs, protocol statistics, and reports.
• Exercise independent judgment to adapt methods beyond standard approaches.
• Maintain statistical integrity of analyses and deliverables per SOPs and regs.
• Lead exploratory analyses, sample size estimation, and modeling to extract insights.
• Present strategy and findings to senior management and influence decisions.
• Mentor biostatistics staff and oversee vendors/CROs.

Skills

Statistical strategy

Cross-functional leadership

R

Markdown/Quarto

git

Unix/Linux

CDISC SDTM/ADaM

Education

Ph.D. in Statistics/Biostatistics

Master's degree with equivalent experience

Tools

R

Quarto/Markdown

Git

Unix/Linux

CDISC SDTM/ADaM

Job description

Denali Therapeutics Inc. seeks a senior biostatistician to design and lead statistical strategy across the full clinical development lifecycle, from first-in-human to pivotal Phase 2/3 trials and NDA/MAA/BLA submissions.

The role requires a Ph.D. in statistics or biostatistics (or an equivalent Master’s with experience) and 6+ years in study-level strategy, with strong R and Markdown/Quarto skills, plus CDISC standards knowledge.