Director, Statistical Programming

Director, Statistical Programming – Bio Space

Alumis Inc. is a precision medicines company with the 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.

We are seeking an experienced Statistical Programming Director to lead programming strategy, execution, and oversight across one or more drug development programs. This role is accountable for ensuring high‑quality programming deliverables in accordance with SOPs, CDISC standards, and global regulatory requirements. It will provide hands‑on technical leadership, manage internal and external programming resources, and partner cross‑functionally to support submissions, publications, and study delivery.

This role is ideal for someone who thrives at the intersection of regulatory rigor and modern data science technologies – with opportunities to shape how we integrate dynamic visualization, automation, and open‑source & AI/ML tools into a high‑quality submission and evidence generation environment.

• Lead statistical programming activities at the study, indication, or program level, including ISS/ISE.
• Develop and execute programming strategies to support regulatory submissions, publications, ad hoc and exploratory analysis, and internal/external communications.
• Ensure programming work adheres to SOPs, CDISC standards as applicable, and regulatory expectations.
• Strong ability to communicate analytical results to non‑technical stakeholders and translate findings into actionable scientific or business decisions.

• Provide technical leadership on programming conventions, standards, specifications, and solutions to complex data challenges.
• Oversee the development and implementation of programming standards, reusable packages utilities, and process improvements.
• Proficiency in R, Python, and/or other programming languages and visualization techniques.
• Knowledge of modern version control systems and open‑source software development techniques.
• Expertise in transforming and analyzing various data types related to clinical trials, including digital health, genomic and biomarkers.
• Ability to analyze complex clinical, preclinical, or real‑world datasets to generate insights that inform drug development strategy.

• Partner closely with Statisticians, Data Management, Clinical Operations, Medical Monitoring, and Medical Writing.
• Participate in review of key study documents (e.g., SAPs, CRFs, DMPs, database specs, DMC charters).
• Serve as a programming point of contact for internal teams and external CRO partners.

• Drive best practices and continuous improvement initiatives, including SOP development and CDISC implementation.
• Understanding of regulatory and compliance standards relevant to data analysis in pharma (e.g., GxP, data integrity, audit readiness).

• Lead and mentor statistical programming staff and oversee CRO/vendor programmers.
• May oversee or manage a programming team responsible for study‑level and project‑level deliverables.

• Lead the continued evolution of our computing environment to incorporate automated workflows, modular code, and modern visualization tools.
• Drive initiatives for leveraging programming software such as R and R shiny, python, and open‑source environments to enable dynamic data exploration.
• Champion reproducible pipelines using tools such as Git, Quarto, and R Markdown.
• Contribute to internal packages, re‑usable code libraries, and process automation to accelerate insights and submissions.
• Explore GenAI, AI/ML applications that will optimize workflow and evolve evidence insight generations.

• Advanced degree (MS or PhD) in statistics, computer science, life sciences, or a related field strongly preferred, with a minimum of 8–10 years of statistical programming experience in drug development.
• Extensive experience leading programming support for global regulatory submissions…