Associate Director/Senior Manager, Data Science (Statistical Programming)

Alumis•South San Francisco, CA

8d•Hybrid

About The Position

Alumis Inc. is a precision medicines company focused on transforming the lives of patients with autoimmune diseases. We are seeking a Data Science leader within Statistical Programming to enhance analytical insights throughout clinical development and ensure high-quality, submission-ready deliverables. This role involves utilizing modern data science techniques, including machine learning and generative AI, to improve statistical programming and analytical insight generation. The position will contribute to both clinical data science (advancing analyses, insights, and submissions) and operational/enterprise analytics (optimizing efficiency, scalability, and decision-making within Biometrics). Depending on the level, the individual will either be a hands-on contributor to studies and programs (Senior Manager) or a strategic program-level leader involved in cross-functional execution (Associate Director).

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.
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.
Bachelor’s degree (or equivalent) with 8+ years of experience, or Master’s with 6+ years (for Senior Manager).
Bachelor’s degree (or equivalent) with 10+ years of experience, or Master’s with 8+ years (for Associate Director).

Nice To Haves

GenAI/Agentic AI application development as a plus.
Therapeutic experience in autoimmune/immunology is a plus.
For Associate Director level: Experience influencing program-level strategy across multiple studies or indications.
For Associate Director level: Demonstrated ability to drive cross-functional alignment and contribute to analytical strategy.
For Associate Director level: Experience mentoring team members and overseeing CRO/vendor deliverables.
For Associate Director level: Exposure to advanced analytics approaches (e.g., causal inference, simulations, RWE integration) in a regulated environment.

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 ML/GenAI models.
Ensure alignment between exploratory analytics and CDISC-based submission deliverables, maintaining documentation for inspection readiness.
Support the analysis of diverse data types including biomarkers, digital endpoints, real-world data, text, and imaging, ensuring interpretability and quality.
Contribute to responses for regulatory queries and the 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 enhance efficiency, reproducibility, and scalability.
Contribute to reproducible analysis pipelines using practices like version control, data engineering, and pipeline automation.
Support the development of dashboards and visualizations (e.g., Shiny, Plotly) for effective insight communication.
Apply data science methods to improve study execution and operational insights, such as enrollment trends, data quality signals, and feasibility.
Partner with Biostatistics, Data Management, Clinical Operations, and other stakeholders to support study and program deliverables.
Participate in the review of key study documents, including SAPs, CRFs, DMPs, and database specifications, to ensure 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 trends related to data science, AI/ML, and analytics in drug development.
Senior Manager: Lead data science activities at the study level, operating as a hands-on contributor delivering analyses and tools.
Associate Director: Provide program-level oversight across multiple studies, influencing data science strategy and cross-functional alignment.
Associate Director: Contribute to shaping data science standards, tools, and longer-term capabilities within Statistical Programming.
Associate Director: Mentor junior team members and guide CRO partners.