Functieomschrijving
Associate Director Pharmacometrics Programming provides timely support to the study team on all programming matters according to the project strategies. Provides project leadership, resource planning/coordinating deliverables within project or across multiple projects. Lead programming support for processing/analyzing/storing data from clinical studies according to a Statistical Analysis Plan, clinical pharmacology report requirement and programming specifications using internal standards and guidelines. 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. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. The incumbent is responsible for addressing administrative functions required for project management such as compilation of resource requirements and milestones, identifying/communicating changes in project requirements that may affect key deliverables at the project level, and working with the department head to develop resource strategies.
This position requires 4 days onsite presence based out of our Tarrytown, NY or Warren, NJ location.
A typical day might include the following:
Lead the programming and QC of analysis datasets, TFL's across multiple projects or standard tools following Regeneron standard data models or user requirements. Representation of PMX programming functions and coordination of activities with cross line functions and support planning/coordinating timelines in data exchange, deliverables. Create, manage and maintain the programming specifications for the analysis datasets utilizing Regeneron tools and methodologies.
Lead the integration of data across studies in support of Exposure-response, PopPK and PopPKPD analysis and 2.7.2.
Provide programming support for all PMX deliverable in HAR request, data driven analysis, publications, conference
Plan and lead the creation and validation of electronic 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
This role might be for you if you:
Expert SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment
Understanding of relational database structure and reporting systems utilizing multiple data delivery applications
Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.
Comprehensive understanding of biostatistics, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis), experienced in data handling, process and analysis and able to understand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner
Mentor junior level staff in therapeutic area requirements. Develop collaborative work environment and be a positive role model.
Good Skilled in use of relevant software, including Window SAS, SAS studio (Base, Stat, Macro, graph), MS-Excel, R programming and/or Python.
Good knowledges in AI use case in statistical programming and data sciences.
To be considered for this opportunity you must have a Master in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline. 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry. Experience in project and people management, and expertise in one or more therapeutic areas is also preferred. SAS Certification desirable in statistics, computer science.
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)