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

We are seeking a Data Science leader within Statistical Programming to advance analytical insights across clinical development while supporting high-quality, submission-ready deliverables. 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. 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). Depending on level, this individual will operate as a hands‑on study/program contributor (Senior Manager) or a program‑level leader influencing strategy and cross‑functional execution (Associate Director). Essential Responsibilities Clinical Evidence Generation, Analytical Insights, and Regulatory Engagement Develop and deliver data science analyses to support clinical development, regulatory submissions, publications, and exploratory analyses. Partner with Biostatistics to support innovative analyses (e.g., simulations, external controls, RWE integration, predictive analytics using ML/GenAI models). Ensure alignment between exploratory analytics and CDISC-based submission deliverables; maintain documentation for inspection readiness. Support analysis of emerging data types (e.g., biomarkers, digital endpoints, real‑world data, text, imaging), ensuring interpretability and quality. Contribute to responses to regulatory queries and preparation of submission materials involving advanced analytics. Technical Execution & Innovation 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‑Functional Collaboration Partner 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. Process, Quality, & Compliance 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 movement related to data science, AI/ML, and analytics in drug development. Leadership and Scope Differentiation Senior Manager: Lead data science activities at the study level; operate as a hands‑on contributor delivering analyses and tools. Associate Director: Provide program‑level oversight across multiple studies; influence data science strategy and cross‑functional alignment. Contribute to shaping data science standards, tools, and longer‑term capabilities within Statistical Programming. Mentor junior team members and guide CRO partners. The Ideal Candidate 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. In addition, for Associate Director level: Experience influencing program‑level strategy across multiple studies or indications. Demonstrated ability to drive cross‑functional alignment and contribute to analytical strategy. Experience mentoring team members and overseeing CRO/vendor deliverables. Exposure to advanced analytics approaches (e.g., causal inference, simulations, RWE integration) in a regulated environment. Education & Experience 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. 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. Alumis Inc. is an equal opportunity employer. The salary range for this position is Senior Manager: $180,000 - $200,000 annually and Associate Director: $200,000 - $220,000 annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program. Other benefits include: 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 kitchen stocked with yummy snacks and drinks! #J-18808-Ljbffr Dormont Manufacturing Co