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Senior Biostatistician

Denali Therapeutics · South San Francisco

Location
South San Francisco
Employment
Full time
Level
Senior
Posted
21 September

About this role

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

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.

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.

Salary Range: $155,000.00 to $202,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.

As published by Denali Therapeutics. Applications are handled on their site.

Skills this posting mentions

LinuxUnixActionable Insights

About Denali Therapeutics

Denali Therapeutics is dedicated to defeating neurodegenerative diseases by breaking through historical barriers in scientific research and clinical development in order to deliver safe and effective medicines to patients and families. Our scientific approach is based on three core principles: rigorous assessment of genetic targets, engineering brain delivery, and using biomarkers to guide development. Our team thrives in a work environment that is scientifically driven, impact-focused, supportive, and collaborative. Our ability to have a positive impact on people’s lives is directly related to the trust we have in each other and our ability to unify our diverse backgrounds and experience behind our purpose to defeat degeneration.

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