Associate Director Statistical Programming - Pharmacometrics

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); On-site; USD 176,100 - 287,300; Full time

Job summary

Regeneron Pharmaceuticals, Inc in Tarrytown, NY, seeks an Associate Director of Pharmacometrics Programming to lead programming support for clinical studies. You'll oversee data analysis, manage project deliverables, and mentor junior staff while ensuring compliance with programming standards.

The ideal candidate possesses over 10 years of programming experience, expert SAS skills, and ideally a master's degree in a relevant field. Join a dynamic environment contributing to groundbreaking therapeutic solutions.

Qualifications

• 10+ years of programming experience in biotechnology or pharmaceutical industry.
• Experience in project and people management.
• SAS Certification in statistics or computer science is desirable.

Responsibilities

• Provide leadership and support for programming in clinical studies.
• Lead programming and QC of analysis datasets.
• Mentor junior staff in therapeutic area requirements.

Skills

Expert SAS programming skills

Understanding of relational database structure

Experience with standardization methodology

Comprehensive understanding of biostatistics

Mentorship skills

Familiarity with R programming and/or Python

Knowledge of AI use cases in statistical programming

Education

Master in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline

Tools

SAS (Base, Stat, Macro, graph)

MS-Excel

Job description

Associate Director Pharmacometrics Programming

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.

Key Responsibilities

• This position requires 4 days onsite presence based out of our Tarrytown, NY or Warren, NJ location.
• 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.

Qualifications

• 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 knowledge in AI use case in statistical programming and data sciences.
• 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.

Salary Range

Salary Range (annually) $176,100.00 - $287,300.00.

Equal Opportunity Employment

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.