A Principal 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.
The incumbent assists in providing guidance in implementing and executing the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. This role also oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses.
- Supporting and/or lead programmer for programming and QC of analysis datasets, TFL's or standard tools following Regeneron standard data models or user requirements.
- Assisting in the coordination of activities and communicate shifting timelines and landmarks.
- Working independently to design and test program logic, coding programs, program documentation and preparation of programs.
- 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.
- Providing documentation and consistent maintenance of code, logs, and output in a regulated environment.
- 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, develop and provide department training for applications and standard tools developed by the department functions group.
- Providing programming support for simple presentations and basic statistical ad-hoc requests. Assisting in the mosophisticatedlex data presentations.
- Participating in department working groups; providing input in development of tools and improvement of processes.
- Ensuring adherence to procedures surrounding retention of data, records, and information.
This role might be for you if:
You can work independently and 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.
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 strong verbal and written communication skills.
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 validated 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.
A BS in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 5+ years of programming experience is required, preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. An MS is preferred and SAS Certification is desirable. Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, 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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.