Manager, Statistical Programming (Open-Source)

Role Summary

The Manager, Open-Source Statistical Programming, will play a pivotal role in driving innovation and implementing cutting-edge technologies within clinical trial data analysis and reporting. This individual will collaborate closely with stakeholders to understand challenges, propose scalable solutions, and lead a team of developers to deliver high-quality open-source programming products. The role encompasses end-to-end responsibilities, including prototyping, iterative development, and production rollout. The candidate will establish standard processes for open-source development and provide technical guidance to junior developers to foster a culture of innovation within the Statistical Programming group.

Responsibilities

• Act as the programming lead for open-source development projects, ensuring timely delivery of high-quality solutions.
• Collaborate with stakeholders to identify requirements, propose solutions, and manage expectations throughout the project lifecycle.
• Oversee the development of prototypes, gather feedback, and iterate to deliver successful products.
• Establish and enforce standard processes for open-source development to ensure consistency and quality.
• Lead the design and development of web applications, AI agents, and other tools using technologies such as R, Python, Shiny, JavaScript, and HTML.
• Develop and maintain R packages and Python libraries to support clinical trial analysis and reporting.
• Ensure proper use of version control tools (e.g., Git, Bitbucket, GitHub) across all projects.
• Provide technical leadership and mentorship to junior developers, ensuring adherence to best practices in open-source programming.
• Guide team members in understanding and implementing CDISC data structures and derivations.
• Foster an environment of continuous learning and innovation within the team.
• Apply knowledge of clinical trial data analysis and reporting to develop solutions that meet industry and regulatory standards.
• Ensure that all regulatory deliverables align with CDISC standards (e.g., SDTM, ADaM) and statistical analysis requirements.
• Support ad hoc statistical analysis requests from senior management.
• Assist in recruiting and onboarding new team members, including contractors and permanent staff.
• Provide feedback to management on team performance and recommend individual goals.
• Plan and allocate resources to ensure deployment of programming deliverables.

Qualifications

• Proficiency in open-source programming languages; strong understanding of clinical trial analysis and reporting; familiarity with CDISC data structures.
• Solid analytical mindset, passion for solutions, and ability to lead cross-functional teams in a highly regulated environment.
• 8–10 years of programming experience, preferably in clinical trial data analysis and reporting, with a focus on open-source technologies.
• Proven experience in project management.

Skills

• Proficient in open-source programming, including R/Python, R Shiny and R package development, and web development frameworks.
• Strong experience with version control tools (e.g., Git, Bitbucket, GitHub).
• Solid understanding of clinical trial analysis, reporting, and CDISC data structures (e.g., SDTM, ADaM).

Education

• Master’s Degree in Computer Science, Statistics, Mathematics, Engineering, Life Sciences, or related area.