Lead statistical strategy and execution for Denali’s core clinical development programs, translating complex data into insights that inform therapeutic decisions for neurodegenerative disease programs.
Compensation
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.
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.
Requirements
PhD in Statistics, Biostatistics, or a related discipline
Designs, develops, tests, and maintains interactive R Shiny applications that support clinical trial activities, ensuring they are scalable and performant for large-scale clinical data analysis.
Responsibilities
Designs, develops, tests, and maintains interactive R Shiny applications that support clinical trial activities
Creates user-friendly applications for statistical review, data exploration, quality control, and reporting
Develops reusable Shiny modules and application frameworks to promote consistency and efficiency
Optimizes application performance, scalability, and usability
Develops reusable programming utilities using R, SAS, and Python
Requirements
Bachelor's degree in Statistics, Computer Science, Mathematics, Data Science, or a related quantitative field
Master's preferred
Nice to have: Active participation in the open-source community
Designs, develops, tests, and maintains interactive R Shiny applications that support clinical trial activities, ensuring they are scalable and performant for large-scale clinical data analysis.
Responsibilities
Designs, develops, tests, and maintains interactive R Shiny applications
Creates user-friendly applications for statistical review, data exploration, quality control, and reporting
Develops reusable Shiny modules and application frameworks to promote consistency and efficiency
Optimizes application performance, scalability, and usability
Develops reusable programming utilities using R, SAS, and Python
Requirements
Bachelor's degree in Statistics, Computer Science, Mathematics, Data Science, or a related quantitative field
Master's preferred
Nice to have: Active participation in the open-source community
Lead senior technical expert in statistical programming for clinical trial data, developing, validating, and delivering SAS deliverables in compliance with CDISC standards.
Compensation
$154,230—$177,726 USD
Responsibilities
Develop and validate CDISC-compliant datasets and reports
Provide SAS programming support for analyses and regulatory deliverables
Adhere to programming timelines and manage risks
Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety teams
Review data management plans and specifications
Requirements
Master's degree in Statistics, Computer Science or related field
The Principal Stat Programmer plays a critical role in ensuring the accuracy and integrity of statistical programming across various clinical projects.
Responsibilities
Develops and validates complex datasets and outputs using SAS programming, ensuring compliance with CDISC standards such as ADaM and SDTM models.
Collaborates with cross-functional teams to optimize statistical programming processes and enhance overall efficiency and accuracy.
Provides technical guidance and expertise on statistical methodologies to support clinical trial projects and departments.
Mentors and guides junior programmers, fostering their growth and development.
Contributes to the continuous improvement of programming workflows and departmental standards.
Requirements
Bachelor's Degree in Statistics, Computer Science or related field
Lead and manage biostatistical programming activities for Amgen’s Biosimilar organization, coordinating with CROs and cross‑functional teams to develop datasets, analysis plans, and submission packages.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 151,838.05USD -205,427.95 USD
Responsibilities
Represent the product programming function and participate in multidisciplinary project team meetings
Collaborate closely with Biosimilar Statisticians and other functional team members
Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans
Review and approve analysis dataset specifications
Review or contribute to data management plans, database development, and edit checks plan
Requirements
BA/BSc or higher degree in quantitative or scientific subjects
Nice to have: MSc or higher degree in quantitative or scientific subjects
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