Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
We are seeking to recruit a Clinical Data Scientist/Statistical Programmer with Biotech/Pharma clinical trials experience, strong statistical programming and problem-solving skills to support our clinical development programs. As a member of the Biometrics team at Denali Therapeutics, the candidate will work closely with clinical study team members and Biometrics colleagues. The candidate will have the opportunity to help shape Denali’s data and programming infrastructure; gain an in-depth understanding of drug development, experience working in a fast-moving industry environment, and gain subject domain knowledge in the field of neurodegeneration.
Provide study execution support: generation of data visualizations or summary reports to support internal decision making and regulatory interactions (IND/CTA filings, annual safety reporting, etc.); providing input for statistical analysis plans, study protocols and clinical study reports; reviewing study randomization specifications; collaborating with Clinical Data Management to provide input for case report form design, data review plans, and external data transfer specifications; collaboration with the study team to review data and manage timelines; assist with oversight of Biometrics CRO deliverables.
Curate data for use with statistical reporting code and analytics applications.
Develop and manage reusable code for interactive data visualization and analytics tools for reporting and exploratory analysis.
Help ensure data quality through: independent QC and review of derived datasets and analysis outputs; programmatic checks of CRF and non-CRF data and issue tracking.
At a minimum, a Bachelor’s degree in Statistics, Biostatistics, Data Science, Mathematics, or related field.
5+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device studies, or intervention studies.
Excellent communication skills and experience representing and leading teams.
Proficiency in R programming (including tidyverse, RMarkdown, Shiny, htmlwidgets, development of R packages), experience applying software development concepts, and use of Git/GitHub for collaboration and versioning of operational, robust, and well documented code.
Basic proficiency in Unix commands and shell scripting.
Applied experience with SDTM and ADaM CDISC data standards and health authority submission of data; or familiarity and exposure to CDISC standards (i.e., SDTM, ADaM) for regulatory submissions and willingness to become a subject matter expert in applying these standards.
Able to create compelling data visualizations to help teams make correct data driven decisions and effectively communicating results to team members.
Solid understanding of statistical principles and methods used in clinical study report analyses.
Advanced degree in Statistics, Biostatistics, Data Science, Mathematics, or related field.
Advanced SAS programming proficiency, in addition to R; prior work experience with pharmacokinetic data and/or clinical data in the neuroscience field; experience using containerization technologies such as Docker, collaborative code version control such as GitHub, and experience with Amazon Web Services and cloud infrastructure.