Director, Statistical Programming

Role Summary

Director-level statistical programming leader responsible for strategy, execution, and oversight across one or more drug development programs. Accountable for high-quality programming deliverables in accordance with SOPs, CDISC standards, and global regulatory requirements. Provides hands-on technical leadership, manages internal and external programming resources, and partners cross-functionally to support submissions, publications, and study delivery. Seeks to integrate dynamic visualization, automation, and open-source/AI/ML tools into a high-quality submission and evidence generation environment. Location: South San Francisco, CA; on-site Tuesday–Thursday; remote candidates may travel regularly for team collaboration.

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, reusable code libraries, and process automation to accelerate insights and submissions.
• Explore GenAI, AI/ML applications that will optimize workflow and evolve evidence insight generations.

Qualifications

• 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.

Education

• Advanced degree (MS or PhD) in statistics, computer science, life sciences, or a related field strongly preferred.

Additional Requirements

• Location: South San Francisco, CA (onsite Tue–Thu). Remote candidates may work off-site but should be willing to travel regularly for team collaboration.