Associate 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 an Associate Manager Statistical Programming to join our Global Development team.

The Associate Manager Statistical Programming will support statistical programming activities across integrated analyses, regulatory submissions, exploratory analyses, and clinical trial data disclosure initiatives. This role will partner closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, and other cross-functional teams to deliver 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 data reporting, and clinical trial programming, along with the ability to collaborate effectively in a global, matrixed environment while maintaining compliance with industry and regulatory requirements.

Key Responsibilities:

Support the development of integrated datasets, pooled ADaM datasets, and statistical reports to meet study and submission objectives.

Deliver high-quality, timely statistical programming outputs and supporting documentation in accordance with established standards and processes.

Contributes to the creation, review, and validation of electronic submission packages supporting global regulatory submissions.

Ensure compliance with global regulatory requirements and industry standards, including FDA, EMA, PMDA, and CDISC standards.

Partner with Clinical Transparency and Trial Disclosure teams to support disclosure-related datasets and reporting deliverables.

Provide technical expertise in SAS programming, troubleshooting programming issues, and supporting process improvements and best practices.

Support inspection readiness efforts and assist with regulatory inspection activities when required.

Collaborate effectively with Biostatisticians, Data Managers, Clinical Teams, and Statistical

Programmers to achieve project milestones and submission timelines.

Contribute to methodology development, tool enhancement, and continuous improvement initiatives within Statistical Programming.

Apply critical thinking and problem-solving skills to resolve complex programming and data-related challenges.

Required Skills & Experience:

Masters or Bachelors degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or a related discipline.

5+ years (MS) or 6+ years (BS) of Statistical Programming experience within the biotechnology, pharmaceutical, or healthcare industry.

Strong hands-on expertise in SAS programming, including Base SAS, SAS Macro, SAS Stat, and SAS Graph.

In-depth knowledge of CDISC standards, including SDTM, ADaM, and Define-XML.

Experience supporting regulatory submissions and compliance with global regulatory authorities such as FDA, EMA, and PMDA.

Proficiency with Pinnacle 21 and experience reviewing, troubleshooting, and resolving validation findings.

Familiarity with electronic submission formats such as eCTD.

Knowledge of R, Python, or other open-source programming languages is highly desirable.

Strong communication, collaboration, and stakeholder management skills.

Demonstrated ability to manage multiple priorities, solve complex technical challenges, and work effectively in a fast-paced global environment.