Alumisย Inc is a precision medicines company withย theย mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.ย
We are seeking a Data Science leader within Statistical Programming to advance analytical insights across clinical development while supporting high-quality, submission-ready deliverables.ย You will employ modern data science methods and tools such as machine learning, generative AI, and agentic AI to strengthen statistical programming and elevate analytical insight generation.ย You will contribute to both clinical data science (enhancing analyses, insights, and submissions) and operational/enterprise analytics (improving efficiency, scalability, and decision-making across Biometrics).ย ย
Depending on level, this individual willย operateย as a hands-on study/program contributor (Senior Manager) or a program-level leader influencing strategy and cross-functional execution (Associate Director).ย
Essentialย Responsibilitiesย
Clinical Evidence Generation, Analytical Insights, andย Regulatory Engagementย ย
- Develop and deliver data science analyses to support clinical development, regulatory submissions, publications, andย exploratoryย analyses.ย
- Partner with Biostatistics to support innovative analyses (e.g., simulations, external controls, RWE integration,ย predictiveย analytics using ML/GenAI models).ย
- Ensure alignment between exploratory analytics and CDISC-based submission deliverables;ย maintainย documentation for inspection readiness.ย
- Support analysis of emerging data types (e.g., biomarkers, digital endpoints, real-world data, text, imaging), ensuring interpretability and quality.ย
- Contribute to responses to regulatory queries and preparation of submission materials involving advanced analytics.ย
Technicalย Executionย &ย Innovationย
- Develop andย maintainย analysisย workflows using SAS and/or open-source tools (R/Python), balancing innovation with compliance.ย
- Build reusable tools, macros,ย templatesย and pipelinesย to improve efficiency, reproducibility, and scalability.ย
- Contribute to reproducibleย analysisย pipelines (e.g., version control,ย dataย engineeringย and pipeline automation).ย
- Support development of dashboards and visualizations (e.g., Shiny, Plotly) to communicate insights effectively.ย
- Apply data science methods to improve study execution and operational insights (e.g., enrollment trends, data quality signals, feasibility).ย
Cross-Functional Collaborationย
- Partner with Biostatistics, Data Management, Clinical Operations, and other stakeholders to support study and program deliverables.ย
- Participate in the review of key study documents (e.g., SAPs, CRFs, DMPs, database specifications) for programming and analysis alignment.ย
- Serve as a point of contact for programming and data science activities with internal teams and CRO partners.ย
- Translate analytical outputs into clear, actionable insights for both technical and non-technical audiences.ย
Process,ย Quality, &ย Complianceย
- Ensure all programming and data science deliverables meet regulatory, industry, and company standards (e.g., CDISC,ย GxP, 21 CFR Part 11).ย
- Contribute to the development and continuous improvement of programming and data science standards, processes, and SOPs.ย
- Stay currentย onย evolving regulatoryย movementย related to data science,ย AI/ML, and analytics in drug development.ย
Leadershipย and Scope Differentiationย ย
- Senior Manager:ย
- Lead data science activities at the study level;ย operateย as a hands-on contributor delivering analyses and tools.
- Associate Director:ย
- Provide program-level oversight across multiple studies; influence data science strategy and cross-functional alignment.ย
- Contribute to shaping data science standards, tools, and longer-term capabilities within Statistical Programming.ย
- Mentor junior team members and guide CRO partners.ย
The Ideal Candidateย
- Strongย experienceย in SAS,ย R or Pythonย for data analysis and visualization.ย
- Experience in Data Science methods and tools: Machine Learning models and model developmentย lifecycle, GenAI/Agentic AI application development as a plusย
- Experience supporting clinical development and regulatory submissions in a pharma/biotech or CRO setting.ย
- Hands-on experience with CDISC standards (SDTM,ย ADaM) and integration with exploratory analytics.ย
- Experience working with diverse data types (clinical, biomarker, or real-world data)ย and data engineering pipeline development.ย
- Experienceย with reproducible research practices (e.g., version control, structured workflows).ย
- Ability to analyze complex datasets and translate findings into actionable insights.ย
- Strong communicationย and collaboration skills across technical and non-technical stakeholders.ย
- Detail-oriented with a strong commitment to quality and accuracy.ย
- Therapeutic experience in autoimmune/immunology is a plus.ย
In addition, for Associate Director level:ย
- Experience influencing program-levelย strategyย across multiple studies or indications.ย
- Demonstrated ability to drive cross-functional alignment and contribute to analytical strategy.ย
- Experience mentoring team members and overseeing CRO/vendor deliverables.ย
- Exposure toย advanced analytics approaches (e.g., causal inference, simulations, RWE integration) in a regulated environment.ย
Education & Experienceย
- Senior Manager:ย
- Bachelor's degree (or equivalent) with 8+ years of experience, orย Master'sย with 6+ yearsย
- Associate Director:ย
- Bachelor's degree (or equivalent) with 10+ years of experience, orย Master'sย with 8+ yearsย
This 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.
The 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. This salary range is an estimate, and the actual salarymayvarybasedon the Company's compensation practices.