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. The Director 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.
Essential Responsibilities:Program Leadership & Strategy
- 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.
Technical Excellence & Oversight
- 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
Cross-Functional Collaboration
- 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.
Process, Compliance & Quality
- 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)
Team Leadership
- 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.
Innovation & Modernization Initiatives
- 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 (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.
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 $200,000 USD to $245,000 USD 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 a kitchen stocked with yummy snacks and drinks!
We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.
Top Skills
What We Do
At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies.
We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects.
Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction.
Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.
