Associate Director/Senior Manager, Data Science (Statistical Programming)
About the role
Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Despite significant advancements in treatments over the past two decades, many patients still face challenges – our mission is to fundamentally improve their outcomes.
Responsibilities
Develop and deliver data science analyses to support clinical development, regulatory submissions, publications, and exploratory analyses.
Partner with Biostatistics to support innovative analyses such as simulations, external controls, RWE integration, and predictive analytics using machine learning and generative AI models.
Ensure alignment between exploratory analytics and CDISC-based submission deliverables; maintain documentation for inspection readiness.
Support analysis of emerging data types including biomarkers, digital endpoints, real-world data, text, and imaging, ensuring interpretability and quality.
Contribute to responses to regulatory queries and preparation of submission materials involving advanced analytics.
Develop and maintain analysis workflows using SAS and/or open-source tools (R/Python), balancing innovation with compliance.
Build reusable tools, macros, templates, and pipelines to improve efficiency, reproducibility, and scalability.
Contribute to reproducible analysis pipelines (e.g., version control, data engineering and pipeline automation).
Support development of dashboards and visualizations (e.g., Shiny, Plotly) to communicate insights effectively.
Apply data science methods to improve study execution and operational insights (e.g., enrollment trends, data quality signals, feasibility).
Cross-functionally collaborate with Biostatistics, Data Management, Clinical Operations, and other stakeholders to support study and program deliverables.
Participate in the review of key study documents (e.g., SAPs, CRFs, DMPs, database specifications) for programming and analysis alignment.
Serve as a point of contact for programming and data science activities with internal teams and CRO partners.
Translate analytical outputs into clear, actionable insights for both technical and non-technical audiences.
Ensure all programming and data science deliverables meet regulatory, industry, and company standards (e.g., CDISC, GxP, 21 CFR Part 11).
Contribute to the development and continuous improvement of programming and data science standards, processes, and SOPs.
Stay current on evolving regulatory movements related to data science, AI/ML, and analytics in drug development.
Requirements
Strong experience in SAS, R or Python for data analysis and visualization.
Experience in Data Science methods and tools: Machine Learning models and model development lifecycle, GenAI/Agentic AI application development as a plus.
Experience supporting clinical development and regulatory submissions in a pharma/biotech or CRO setting.
Hands-on experience with CDISC standards (SDTM, ADaM) and integration with exploratory analytics.
Experience working with diverse data types (clinical, biomarker, or real-world data) and data engineering pipeline development.
Experience with reproducible research practices (e.g., version control, structured workflows).
Ability to analyze complex datasets and translate findings into actionable insights.
Strong communication and collaboration skills across technical and non-technical stakeholders.
Detail-oriented with a strong commitment to quality and accuracy.
Therapeutic experience in autoimmune/immunology is a plus.
Qualifications
Senior Manager: Bachelor’s degree (or equivalent) with 8+ years of experience, or Master’s with 6+ years
Associate Director: Bachelor’s degree (or equivalent) with 10+ years of experience, or Master’s with 8+ years
Benefits
Health insurance premiums paid at 90% for employee, 80% for dependents
Free access to Genentech Bus & Ferry Share program
$100 monthly cell phone stipend
Unlimited PTO for Exempt employees
Free onsite gym and a kitchen stocked with yummy snacks and drinks!
Pay
Salary range for this position is Senior Manager: $180,000 USD - $200,000 USD annually and Associate Director: $200,000 USD - $220,000 USD annually.
Schedule
The role is located in South San Francisco, CA, with an on-site presence expected Tuesday through Thursday. Remote candidates may remain off-site but should be willing to travel regularly for team collaboration.