Principal Statistical Programmer (Pharmacometrics)

A Principal Pharmacometrics Programmer provides timely support to study teams on all programming matters according to project strategies. Their responsibilities include creating initial Tables, Figures, and Listings (TFLs) for Clinical Pharmacology (CP) reports based on study Statistical Analysis Plans (SAPs) and CP TFL standards, and finalizing these lists with input from authors and writers. They lead programming support for processing, analyzing, and storing data from clinical studies in accordance with SAPs, clinical pharmacology report requirements, Population PK/PD analysis requirements, and programming specifications—all while adhering to internal standards and guidelines. The role involves providing documentation and consistent maintenance of code, logs, and outputs in a regulated environment, as well as implementing and executing programming and project standards. The position's scope also includes evaluating and developing study requirements and validation plans. The Principal Pharmacometrics Programmer works independently to design and test program logic, code programs, document processes, and prepare programs. Additionally, they lead and participate in projects designed to support ongoing clinical studies' requests for both statistical and non-statistical analyses. This position requires 4 days onsite presence based out of our Tarrytown, NY or Warren, NJ location. In this role, a typical day might include the following: · Lead programmer for programming and QC of analysis datasets, TFL's of 1 or more projects 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. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies. Contribute to standard tools or macros development. · Integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis and 2.7.2. Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations. · Lead and execute the creation and validation of electronic data submission packages according to CDISC standards (i.e. annotated CRF, data export files, CSDRG, ADRG, 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 report · Participate in department working groups; participate/provide input in development of tools and improvement of processes. This role may be for you if have: · Strong SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment · Good understanding of relational database structure. · Understanding of reporting systems utilizing multiple data delivery applications; Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards. · 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. · Comprehensive 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 · Experience in project management with supervision. Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel. · 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 5+ 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 culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. 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) $109,900.00 - $179,300.00 Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.