Senior Biostatistician – Strategy Lead for Phase 3 Programs

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics seeks an experienced biostatistician to shape the statistical strategy across the clinical development lifecycle, from first-in-human to pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.

The role requires a Ph.D. in Statistics/Biostatistics (or equivalent with 6+ years) and strong R/Markdown/Quarto skills, plus CDISC SDTM/ADaM knowledge. You will mentor biostatisticians, lead cross-functional teams, and influence regulators and vendors.

Qualifications

• Ph.D. in Statistics, Biostatistics, or related field with 6+ years of experience in study level strategy and decision making.
• Late-stage (Phase 3) clinical trial planning, conduct, and reporting experience.
• Strong programming in R and Markdown/Quarto; working knowledge of git and Unix/Linux environments.

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.
• Lead 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.

Skills

Statistical strategy

Mentoring

Regulatory interactions

Education

PhD in Statistics/Biostatistics

Master's degree with equivalent experience

Tools

R

Markdown/Quarto

Git

Unix/Linux

CDISC SDTM ADaM

Job description

Denali Therapeutics seeks an experienced biostatistician to shape the statistical strategy across the clinical development lifecycle, from first-in-human to pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.

The role requires a Ph.D. in Statistics/Biostatistics (or equivalent with 6+ years) and strong R/Markdown/Quarto skills, plus CDISC SDTM/ADaM knowledge. You will mentor biostatisticians, lead cross-functional teams, and influence regulators and vendors.