Regeneron Pharmaceuticals, Inc

Associate Director Statistical Programming - Pharmacometrics

Regeneron Pharmaceuticals, Inc$176K — $287K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Master's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
  • 10+ years of programming experience in clinical trial data processing.
  • Expertise in SAS (Base, Stat, Macro, graph) in a clinical data environment.
  • Experience with standardization methodology and CDISC data standards.
  • Strong knowledge in biostatistics and pharmaceutical clinical development.

Responsibilities

  • Lead programming and QC of analysis datasets and TFL's across multiple projects.
  • Coordinate data integration for Exposure-response and PopPK analysis.
  • Provide programming support for PMX deliverables including HAR requests and publications.
  • Create and validate electronic submission requirements such as annotated CRF and define documents.
  • Collaborate with multidisciplinary study teams for clinical trial analysis and reporting.

Benefits

  • Collaborative work environment fostering mentorship and professional development.
  • Opportunity to work with cutting-edge statistical programming and AI applications.
  • Onsite presence required for team collaboration in Tarrytown, NY or Warren, NJ.
Full Job Description

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.

Salary Range (annually)

$176,100.00 - $287,300.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

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Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

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Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

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Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

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