Senior Biostatistician: Strategy & Analytics Leader

Denali Therapeutics; South San Francisco (CA); On-site; USD 155,000 - 202,000; Full time

Job summary

Denali Therapeutics is seeking a senior biostatistician to lead the statistical strategy and execution for our core clinical programs in neurodegenerative diseases. The role combines hands‑on statistical rigor with cross‑functional influence to ensure analyses meet regulatory and scientific standards.

You will oversee external vendors, perform exploratory analyses, and present statistical considerations to senior management, maintaining cutting‑edge methods and industry data standards.

Qualifications

• Typically requires a PhD in Statistics, Biostatistics, or a related discipline with 3+ years of pharmaceutical/biotech experience.
• Demonstrated expertise in statistical methodology and its application to pharmaceutical/biotechnology problems.
• Strong programming proficiency in R and Markdown/Quarto, with working knowledge of git and Unix/Linux environments.
• Familiarity with industry data standards, including CDISC, SDTM, and ADaM.
• Strong analytical, collaboration, and communication skills, with demonstrated ability to work cross‑functionally with research and clinical colleagues.

Responsibilities

• Leads development of key clinical study deliverables, including statistical analysis plans, protocol statistical sections, and clinical study reports.
• Ensures statistical integrity and accuracy of analysis and reporting deliverables, meeting pre‑specified requirements, internal SOPs, and external regulatory standards.
• Conducts hands‑on exploratory analyses, sample size estimation, and modeling/simulation; builds tools to extract insights from data.
• Interprets and presents data and statistical considerations to internal project teams and senior management.
• Oversees Biostatistics vendors and contract research organizations, providing quality oversight of in‑house and external statistical deliverables.
• Maintains current expertise in statistical methodology, indication‑specific drug development trends, and the regulatory landscape.

Skills

Statistical methodology

Cross-functional collaboration

Data analysis & interpretation

R programming

Markdown/Quarto

Git

Unix/Linux

Communication skills

Education

PhD in Statistics/Biostatistics or related field with 3+ years pharma/biotech experience

Master’s degree with equivalent related experience

Tools

R

Git

Unix/Linux

CDISC SDTM ADaM

Job description

Denali Therapeutics is seeking a senior biostatistician to lead the statistical strategy and execution for our core clinical programs in neurodegenerative diseases. The role combines hands‑on statistical rigor with cross‑functional influence to ensure analyses meet regulatory and scientific standards.

You will oversee external vendors, perform exploratory analyses, and present statistical considerations to senior management, maintaining cutting‑edge methods and industry data standards.