Manager – Statistical Programming

Role Summary:

At Regeneron, we are committed to advancing science and delivering life-changing medicines to patients worldwide. We are looking for a Manager Statistical Programming to join our Global Development team.

The Manager Statistical Programming will lead statistical programming activities across integrated analyses, regulatory submissions, exploratory analyses, and clinical trial data disclosure initiatives. This role will play a key leadership position within Statistical Programming, partnering with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, and other cross-functional stakeholders to ensure timely delivery of high-quality programming outputs that support global clinical development and regulatory objectives.

This position requires strong expertise in SAS programming, CDISC standards, regulatory submissions, integrated reporting, clinical trial programming, and team leadership. The successful candidate will lead programming deliverables, provide technical oversight, support inspection readiness activities, and contribute to process improvements that enhance quality, compliance, and operational efficiency.

Key Responsibilities:

• Lead statistical programming activities for integrated datasets, pooled analyses, and clinical reporting deliverables across development programs.
• Oversee the creation of integrated dataset specifications, including pooled ADaM datasets, ensuring compliance with programming standards and processes.
• Partner with study programming teams to support the creation, review, and validation of electronic submission packages for global regulatory submissions.
• Ensure compliance with global regulatory requirements and industry standards, including FDA, EMA, PMDA, and CDISC guidelines.
• Collaborate with Clinical Transparency and Trial Disclosure teams to deliver datasets and outputs required for disclosure activities.
• Provide technical leadership and subject matter expertise in SAS programming, submission standards, tools development, and process optimization.
• Troubleshoot and resolve complex programming, validation, and submission-related issues while driving best practices across the team.
• Lead or support initiatives that improve efficiency, standardization, automation, and regulatory compliance across programming functions.
• Support inspection readiness activities and provide programming expertise during regulatory inspections and audits.
• Mentor and guide statistical programmers, fostering technical development and strengthening programming capabilities across the organization.
• Collaborate with global stakeholders across Statistical Programming, Biostatistics, Clinical Development, Data Management, Regulatory Affairs, and other functional areas to achieve submission and reporting objectives.

Required Skills & Experience:

• Masters or Bachelors degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.
• Minimum 6+ years (MS) or 7+ years (BS) of Statistical Programming experience within biotechnology, pharmaceutical, or healthcare organizations.
• Strong expertise in SAS programming, including Base SAS, SAS Macro, SAS Stat, and SAS Graph in a clinical data environment.
• Extensive knowledge of CDISC standards, including SDTM, ADaM, and Define-XML.
• Experience supporting regulatory submissions and ensuring compliance with FDA, EMA, PMDA, and other global regulatory requirements.
• Hands-on experience with Pinnacle 21, including review, validation, troubleshooting, and resolution of compliance findings.
• Knowledge of electronic submission formats such as eCTD.
• Experience leading projects, mentoring team members, and collaborating across global functional teams.
• Strong problem-solving, analytical thinking, communication, and stakeholder management skills.
• Knowledge of R, Python, or other open-source programming languages is highly desirable.
• Ability to manage multiple priorities in a fast-paced, highly regulated global environment.