Principal Statistical Programmer (Pharmacometrics)
Regeneron Pharmaceuticals, Inc, Raleigh, NC, United States
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 reports based on study 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.
Typical day responsibilities
Lead programmer for programming and QC of analysis datasets, TFLs of 1 or more projects following Regeneron standard data models or user requirements. Represent PMX programming functions and coordinate activities with cross‑line functions, communicating 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 PopPK/PD analysis and 2.7.2. Provide programming support for simple presentations and basic statistical ad‑hoc requests, and assist in more complex data presentations.
Lead and execute the creation and validation of electronic data submission packages according to CDISC standards (e.g., 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 and provide input in development of tools and improvement of processes.
Skills and experience required
Strong SAS programming skills (Base, Stat, Macro, graph) in a clinical data environment.
Good understanding of relational database structure.
Experience with implementing standardization methodology and creation of current CDISC data standards.
Ability to take directives, work independently, and exercise judgment in interpreting, modifying, and adapting procedures.
Comprehensive understanding of biostatistics, pharmaceutical clinical development (safety deliverables, efficacy analysis) and experience in data handling and analysis, including pharmacokinetics, immunogenicity, exposure‑response analysis.
Experience in project management with supervision, organizing and managing multiple assignments with challenging timelines.
Proficiency with relevant software, including Windows SAS, SAS EG, MS‑Excel, R/R‑Studio.
Qualifications
MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
5+ years of programming experience, preferably processing clinical trial data in biotechnology, pharmaceutical or health‑related industry.
Benefits Benefits may include health and wellness programs (medical, dental, vision, life, 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.
Equal Opportunity Statement 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.
Salary Range (annually) $109,900.00 – $179,300.00
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This position requires 4 days onsite presence based out of our Tarrytown, NY or Warren, NJ location.
Typical day responsibilities
Lead programmer for programming and QC of analysis datasets, TFLs of 1 or more projects following Regeneron standard data models or user requirements. Represent PMX programming functions and coordinate activities with cross‑line functions, communicating 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 PopPK/PD analysis and 2.7.2. Provide programming support for simple presentations and basic statistical ad‑hoc requests, and assist in more complex data presentations.
Lead and execute the creation and validation of electronic data submission packages according to CDISC standards (e.g., 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 and provide input in development of tools and improvement of processes.
Skills and experience required
Strong SAS programming skills (Base, Stat, Macro, graph) in a clinical data environment.
Good understanding of relational database structure.
Experience with implementing standardization methodology and creation of current CDISC data standards.
Ability to take directives, work independently, and exercise judgment in interpreting, modifying, and adapting procedures.
Comprehensive understanding of biostatistics, pharmaceutical clinical development (safety deliverables, efficacy analysis) and experience in data handling and analysis, including pharmacokinetics, immunogenicity, exposure‑response analysis.
Experience in project management with supervision, organizing and managing multiple assignments with challenging timelines.
Proficiency with relevant software, including Windows SAS, SAS EG, MS‑Excel, R/R‑Studio.
Qualifications
MS (BS) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
5+ years of programming experience, preferably processing clinical trial data in biotechnology, pharmaceutical or health‑related industry.
Benefits Benefits may include health and wellness programs (medical, dental, vision, life, 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.
Equal Opportunity Statement 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.
Salary Range (annually) $109,900.00 – $179,300.00
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