Senior Manager, Statistical Programming

A Senior Manager Statistical Programming provides timely support to the project team on all programming matters according to the project strategies within a therapeutic area. As an integral part of a project team, the incumbent provides project leadership and contributes to the programming support for processing data from clinical studies. Project requirements will be identified according to a Statistical Analysis Plan, programming specifications or user requirements/design documents using internal standards and guidelines. The incumbent is responsible for leading the programming aspect of the project, both internally or CROs, for all programming deliverables and participates in the identification and development of programming standards and macro development to facilitate the creation of statistical deliverables from a single study through to regulatory approval, product launch, and annual reports. May be asked to oversee special projects / work with clinical task force. Meets statistical adhoc requests of senior management.

As a Senior Manager, A typical day may include:

• Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming within a therapeutic area using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming deliverables. Manage and coordinate programming and QC of analysis datasets and TFLs following Regeneron standard data models and/o integration of data across studies in support of CSS/CSE and esub deliverables.
• Implement and mentor others on the use of department standardization tools or therapeutic area standard analysis when programming clinical data or system application deliverables.
• Contribute to programming development and quality control of the programming deliverables utilizing Regeneron tools and methodologies.
• Programming representative within a therapeutic area in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, programming representative for an application development to the user audience.
• Develop data models, programming standards and code, and training end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
• Mentor junior level staff in therapeutic area requirements. Develop collaborative work environment and be a positive role model.
• Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group.

• Masters Degree and 8-10 years of relevant experience
• SAS Certification desirable.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides 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! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter.

Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location., Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.