Manager, Statistical Programming (Open-Source)

Regeneron Pharmaceuticals

4d • Onsite

About The Position

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 at Regeneron Pharmaceuticals. 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 also establish standard processes for open-source development, provide technical guidance to junior developers, and contribute to building a culture of innovation within the Statistical Programming group. As a Manager, Statistical Programming, a typical day may include: Leading projects from conception to implementation, ensuring compliance with internal standards and regulatory requirements. The scope includes developing web applications, AI-driven tools, and other innovative solutions. This role might be for you if you can: Leadership and Project Management: 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. Open-Source Development: 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. Technical Guidance and Mentorship: 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. Clinical Trial Analysis and Reporting: 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. Team Development and Resource 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. To be considered for this opportunity, you must have the following: This position requires proficiency in open-source programming languages, a strong understanding of clinical trial analysis and reporting, and familiarity with CDISC data structures. The ideal candidate will have a solid analytical mindset, a passion for solutions, and the ability to lead cross-functional teams in a highly regulated environment.

Requirements

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

Responsibilities

• Leading projects from conception to implementation, ensuring compliance with internal standards and regulatory requirements. The scope includes developing web applications, AI-driven tools, and other innovative solutions.
• 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.

Benefits

• comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
• award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees