regeneron
Senior Statistical Programmer
Job description
The Senior Statistical Programmer provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines.
In this role, a typical day may include
- Being responsible for projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses.
- Supporting and/or leading programmer for programming and QC of analysis datasets, TFL's or standard tools following Regeneron standard data models or user requirements.
- Being accountable for integration of data across studies in support of CSS/CSE.
- Creating, managing, and maintaining the programming specifications for the analysis datasets using Regeneron tools and methodologies.
- Supporting creation and validation of e-submission requirements (i.e. annotated CRF, data export files, define documents).
- Working in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If applicable, developing and providing department training for applications and standard tools developed by the department functions group.
This role may be for you if
- You can work independently to design and test program logic, coding programs, program documentation and preparation of programs.
- You have understanding of relational database structure.
- You have validated understanding of reporting systems using multiple data delivery applications and with implementing standardization methodology.
- You have some project management experience with supervision. Ability to organize and handle multiple assignments with ambitious timelines for a limited number of personnel.
- You have proven problem solving and innovative skills that demonstrate initiative and motivation.
- You have familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
To be Considered: BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 3+years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. A Master's degree is preferred. SAS Certification desirable. Knowledge of pharmaceutical clinical development (i.e. understanding safety results, efficacy analysis) and ability to provide programming support needs for BLA and other regulatory submissions is vital. Knowledge in creation of current CDISC data structures is also needed
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$88,500.00 - $144,500.00


