Senior Biostatistician
Denali Therapeutics
Summary
This role drives the statistical strategy and execution behind Denali's core clinical development programs, translating complex data into insights that inform therapeutic decisions for neurodegenerative disease programs. The position combines hands-on statistical rigor with cross-functional influence, ensuring analyses meet the highest standards of scientific and regulatory integrity. It also provides oversight of external statistical service providers to ensure consistent, high-quality delivery across programs.
Job description
Key Accountabilities / Core Job 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.
Qualifications/Skills:
- Typically requires a PhD in Statistics, Biostatistics, or a related discipline with 3+ years of pharmaceutical/biotech experience; or a Master's degree in a related discipline with equivalent related 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.
Requirements
- PhD in Statistics, Biostatistics, or a related discipline with 3+ years of pharmaceutical/biotech experience; or a Master's degree in a related discipline with equivalent related 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.
Benefits
- 401(k)
- Healthcare coverage
- ESPP
Company overview
Denali Therapeutics is a pioneering biotechnology company focused on developing innovative therapeutics for neurodegenerative and lysosomal storage diseases. Founded in 2015 and headquartered in South San Francisco, California, the company has developed a proprietary TransportVehicle™ (TV) platform designed to enable biotherapeutics to cross the blood-brain barrier, addressing one of the most significant challenges in treating central nervous system disorders. Denali's pipeline includes promising candidates for conditions such as Hunter syndrome (MPS II), Parkinson's disease, frontotemporal dementia, Sanfilippo syndrome (MPS IIIA), and MPS I, with several programs in advanced clinical development stages. The company collaborates with major pharmaceutical partners including Biogen and Sanofi, leveraging its platform technology to create a new class of barrier-crossing therapeutics. With approximately 500-1,000 employees and operations spanning multiple locations including Salt Lake City, Denali Therapeutics represents a leading force in neuroscience drug development, combining deep scientific expertise with a patient-centric approach to transform treatment paradigms for serious neurological conditions.