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 mentorship 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. Works independently to craft and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment
A typical day as a Principal Programmer can include:
• Support and/or lead programmer for programming and QC of analysis datasets, TFLs or standard tools following Regeneron standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones.
• Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
• Support creation and validation of submission requirements (i.e. annotated CRF, data export files, define documents).
• Work 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.
• Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations.
• Participate in department working groups; provide input in development of tools and improvement of processes.
To be considered for this role, you must have:
Education
• Master’s Degree
• Also acceptable - MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 3+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.
• SAS, (Base, Stat, Macro, graph).
Experience
• 3 – 5 Years
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.
Salary Range (annually)
Top Skills
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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