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 candidate27s 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 Denali27s good faith estimate as of the date of publication and may be modified in the future.
