Senior Biostatistician

Denali Therapeutics Inc; South San Francisco (CA); Vor Ort; USD 155.000 - 202.000; Vollzeit

Benefits dieser Stelle

401k

Healthcare coverage

ESPP

Employee benefits package

Zusammenfassung

Denali Therapeutics Inc. in South San Francisco, CA seeks a senior Biostatistician to lead the statistical strategy and execution for core clinical programs. You will translate complex data into insights to inform neurodegenerative disease decisions, and oversee external vendors to ensure high-quality delivery.

You will conduct hands-on analyses, sample size estimation, and modeling, and present results to project teams and senior management, maintaining regulatory rigor and robust science.

Qualifikationen

• PhD in Statistics or Biostatistics with 3+ years in pharma/biotech.
• Demonstrated expertise in statistical methodology for pharma problems.
• Strong coding in R; familiarity with Unix/Linux, Git.

Aufgaben

• Leads development of clinical study deliverables, including SAS/analyses plans and reports.
• Ensures statistical integrity and regulatory compliance of deliverables.
• Conducts hands-on exploratory analyses, sample size estimation, and modeling.
• Interprets and presents data to internal teams and senior management.
• Oversees Biostatistics vendors and CROs for quality delivery.
• Maintains current expertise in statistics and regulatory landscape.

Kenntnisse

R

Markdown/Quarto

Git

Unix/Linux

Statistical methods

Cross-functional collaboration

Ausbildung

PhD in Statistics/Biostatistics

Master's in related discipline

Tools

CDISC

SDTM

ADaM

Jobbeschreibung

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.

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.

"Life at Denali" is a living reflection of our values: trust, unity, grit and growth. These are not just words we share—they shape how we show up, collaborate and push boundaries together. From the lab to the community, across functions and milestones, our culture thrives on shared purpose and relentless pursuit.