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Alumis · 1 day ago

Director, Statistical Programming

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$200K/yr - $245K/yr

8+ years exp

Alumis Inc. is a precision medicines company focused on transforming the lives of patients with autoimmune diseases. They are seeking an experienced Statistical Programming Director to lead programming strategy and execution across drug development programs, ensuring high-quality deliverables and compliance with regulatory standards.

BiotechnologyHealth CareLife ScienceMedicalPrecision Medicine

Responsibilities

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

Qualification

Statistical programmingRPythonCDISC standardsData visualizationOpen-source softwareRegulatory submissionsTeam leadershipCross-functional collaborationCommunication skillsDetail-oriented

Required

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 (FDA, EMA, CDE)

Prior experience in early- and late-phase studies with integrated analyses is strongly preferred

Advanced programming skills in R, Python with strong knowledge in clinical data visualization and exploration

Working knowledge in open-source software development environments

Comfortable working in fast-paced, ambiguous environments and proactively identifying data-driven opportunities

Collaborative mindset and willingness to mentor team members and contribute to a culture of knowledge sharing

Demonstrated ability to lead programming teams and oversee vendor partnerships

Strong cross-functional communication skills, able to influence and collaborate effectively

Detail-oriented, meticulous, and committed to quality and accuracy