Principal Data Scientist/Statistical Programmer (R)

Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational

medicine.

The Opportunity

We seek to recruit a Principal Data Scientist/Statistical Programmer to lead data science activities for the registrational studies.

The candidate will be able to help shape Denali's data and programming infrastructure, support the adoption of R in a regulated environment, and gain an in-depth understanding of drug development in neurodegeneration in a fast-moving industry environment.

The ideal candidate will have experience supporting drug development and clinical study projects using R and other open-source platforms; will have excellent statistical programming and problem-solving skills; The candidate will take the initiative to stay current on technologies and methods; will support the use of open-source software for clinical trial reporting within Denali, come up with innovative solutions to challenging problems, and work with Biometrics management to help set the overall strategic direction of the group.

Primary Responsibilities

Represent data science to project and study teams. Lead data science deliverables, including generating data visualizations or summary reports to support internal decision-making and regulatory interactions (IND/CTA filings, annual safety reporting, BLA/NDA, etc.) by providing input for the study data standardization plan (SDSP), statistical analysis plans (SAP), study protocols, and clinical study reports(CSR); collaborating with Clinical Data Management on case report form(CRF) design, data review plans, and external data transfer specifications; collaborating with the study team to review data and manage timelines;

• Provide technical leadership in designing, developing, and validating clinical trial data for regulatory submissions in CDISC standards.

• Oversee, review, and execute statistical programming deliverables related to study monitoring, clinical study reports, and regulatory submissions, including integrated analysis (ISS and ISE) and regulatory query responses.

• Effectively manage and oversee Biometrics CRO deliverables and contract details.

• Develop and manage reusable code for interactive data visualization, exploratory analysis, and statistical summaries.

• Lead and support the Biometrics Team in efforts to build, maintain, and continuously improve a R/SAS infrastructure suitable for regulatory submissions.

• Work with the Biometrics team to establish innovative processes to ensure high data quality, reporting of analysis results, and analysis reproducibility.

• Effectively interact with external programming resources, including contributing to developing and reviewing contracts and feedback on performance.

• Identify, develop, and maintain statistical programming standards, processes, and SOPs.

• Act as a mentor and train data scientists/statistical programmers regarding programming techniques, project management, and implementation of standards.

• Contribute to the recruitment and retention of both permanent and contract talent.

Requirements

Must Have

• At a minimum, a bachelor's degree in Data Science, Mathematics, Statistics, Biostatistics, Bioinformatics, Biological Science, or a related field is required.

• At least six years of experience as a statistical programmer on a biotech/pharma clinical development biometrics team or with a similar team, as well as experience supporting drug development, medical device development, or intervention studies.

• In-depth experience with CDISC standards (i.e., SDTM, ADaM) for regulatory submissions and advanced knowledge of regulatory & compliance requirements for the Biometrics function.

• Prior experience leading one or more registrational studies in CDISC data standards.

• Able to demonstrate a solid understanding of statistical principles and methods in clinical study reports or scientific publication analyses.

• Strong R programming skills (including tidyverse, Quarto, shiny, HTML widgets, and R package development).

• Experience applying software development concepts and proficiency in using Git/GitHub to create operational, robust, well-documented code.

• Strong data wrangling skills using R and database languages (e.g., SQL, NoSQL).

• Able to create compelling data visualizations to help teams make correct data-driven decisions and effectively communicate results to team members.

• Experience in mentoring and training others on best programming and analysis practices.

• Excellent communication skills and experience representing and leading teams.

Preferred

• A master's degree in Data Science, Mathematics, Statistics, Biostatistics, Bioinformatics, Biological Science, or a related field.

• Prior experience leading one or more global regulatory submissions (NDA/BLA/MAA) in CDISC data standards.

• Able to work in a Linux/Unix environment (including shell scripting).

• Prior work experience with pharmacokinetic data and the neuroscience field.

• Proficiency in languages or tools other than R (e.g., SAS, Python, Java, C++), containerization technologies such as Docker, Amazon Web Services, and experience with applying machine learning techniques.

• Keen interest in applying artificial intelligence techniques, such as LLM (Large Language Models), for proof-of-concept projects aimed at enhancing workflow efficiency and effectiveness.

Salary Range: $167,000.00 - $203,333.00. 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.

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