Associate Director Statistical Programming - Pharmacometrics

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

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 are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

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For jobs in Canada: this posting is for an existing position.

Salary Range (annually)