The Manager Statistical Programming provides timely support to the study team on all programming matters according to the project strategies. Provide project leadership and programming support for processing data from clinical studies. Provides guidance in implementing and performing the programming and project standards. Lead the programming aspect of a project, both internally or CROs, for all programming results from the single study through to regulatory approval, product launch, data monitoring boards and annual reports.
In this role, a typical day might include the following:
- Develop an expertise within a therapeutic area or standard tool.
- Work with minimal direction to perform, coordinate and be responsible for the preparation, execution, reporting and documentation of a project.
- Function as a lead programmer in the development and QC of tables, listings, graphs, or systems in support of analysis requirements using Regeneron tools and methodologies and current industry standards (i.e. CDISC SDTM / ADaM)
- Manage the effort, including e-submssion results, using appropriate tools to track, allocate and summarize extent of work required, progress and completion of programming results. Provide programming support for sophisticated presentations and more complex statistical ad-hoc requests.
This role may be for you if:
- Work independently, exercise judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
- Experience in pharmaceutical clinical development in at least one therapeutic area and ability to provide programming support needs for BLA and other regulatory submissions
- Possess Advanced SAS programming skills, preferably in a clinical data environment.
- Experience in project start-up through submission.
- Knowledge in creation of current CDISC data structures.
- Strong understanding of relational databases and experience working with complex data systems.
To be considered:
We seek a Bachelor’s degree required. MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field preferred. 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry is also needed, including some project and/or people management
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
