Onsite Lead Programmer - Statistical Programming Manager

Regeneron Pharmaceuticals; Cambridge (MA); On-site; USD 128,600 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager to provide timely programming support for clinical study data and lead the programming workstream from study inception through regulatory submission and product launch. This onsite role emphasizes leadership of the programming team, adherence to internal standards, and collaboration with CROs to ensure quality deliverables.

Responsibilities include overseeing SDTM/ADaM development, managing e submissions, and guiding junior staff while maintaining

Qualifications

• Master’s degree required.
• 8–10 years of relevant work experience, or 5+ years with a Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline.

Responsibilities

• Lead the programming aspect of a project for all programming deliverables from study through regulatory approval, product launch, data monitoring boards and annual reports.
• Oversee documentation and ensure maintained code, logs, and output within a regulated environment.
• Act as programming representative to the study team to ensure timely, quality analysis and reporting of clinical trials up to regulatory approval.
• If applicable, lead an application development and act as the programming representative to the user audience.
• Determine resource requirements for the department’s therapeutic area or function.
• Review resumes, screen and interview candidates for contractor and permanent positions.
• Provide feedback to management on team performance and set yearly goals.

Skills

SAS Certification

Project management

People management

Education

Master’s Degree

Job description

Regeneron Pharmaceuticals is seeking a Manager to provide timely programming support for clinical study data and lead the programming workstream from study inception through regulatory submission and product launch. This onsite role emphasizes leadership of the programming team, adherence to internal standards, and collaboration with CROs to ensure quality deliverables.

Responsibilities include overseeing SDTM/ADaM development, managing e submissions, and guiding junior staff while maintaining