A senior pharmacometrics programmer provides timely support to the study team on all programming matters according to the project strategies.
Processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan, clinical pharmacology report requirement, Population PK/Population PK/PD analysis requirement and programming specifications using internal standards and guidelines.
This is a hybrid position with 3 days onsite requirement based out of our Tarrytown, NY location.
In this role, a typical day might include the following:
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Lead/support programming and QC of analysis datasets, TFL's of multiple studies following Regeneron standard data models or user requirements. Representation of PMX programming functions and coordination of activities with cross line functions and communicate shifting timelines and milestones under guidance. Create, manage and maintain the programming specifications for the analysis datasets using Regeneron tools and methodologies.
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Integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis
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Creation and validation of electronic submission package (i.e. annotated CRF, data export files, CSDRG, ADRG and define documents).
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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
This role may be for you if have:
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Good SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment
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Good understanding of relational database structure.
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Understanding of reporting systems utilizing multiple data delivery applications
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Good Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
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Able to take directives, works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
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Good understanding of biostatistics, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis), experienced in data handling, process and analysis and able to undstand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner
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Skilled in use of relevant software, including Window SAS, SAS EG (Base, Stat, Macro, graph), MS-Excel, R,/R-Studio etc.
To be considered for this opportunity you must have:
MS. (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.
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)
$92,500.00 - $151,100.00
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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