Statistical programmer Jobs in USA

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 (CP) reports based on study Statistical Analysis Plans (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.

In this role, a typical day might include the following:

· Lead programmer for programming and QC of analysis datasets, TFL's of 1 or more projects following Regeneron standard data models or user requirements. Representation of PMX programming functions and coordination of activities with cross line functions and communicate 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 PopPKPD analysis and 2.7.2. Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations.

· Lead and execute the creation and validation of electronic data submission packages according to CDISC standards (i.e. 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; participate/provide input in development of tools and improvement of processes.

This role may be for you if have:

· Strong SAS programming skills (SAS (Base, Stat, Macro, graph) in a clinical data environment

· Good understanding of relational database structure.

· Understanding of reporting systems utilizing multiple data delivery applications; Strong Experience/knowledge with implementing standardization methodology, creation of current CDISC data standards.

· Able to take directives, works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.

· Comprehensive understanding of biostatistics, pharmaceutical clinical development (i.e. safety deliverables, efficacy analysis), experienced in data handling, process and analysis and able to undstand/perform Pharmacokinetics, immunogenicity, exposure response analysis in timely manner

· Experience in project management with supervision. Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel.

· Skilled in use of relevant software, including Window SAS, SAS EG (Base, Stat, Macro, graph), MS-Excel, R,/R-Studio etc.

To be considered for this opportunity you must have:

MS. (BS.) in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field with 5+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.