R Programming Lead (Statistical Programming)
Role details
Job location
Tech stack
Job description
Join a sponsor-dedicated team and contribute to the advancement of in-house study activities over time. As the R Programming Lead , you will provide technical expertise to the Statistical Programming team, ensuring the delivery of high-quality solutions that meet both internal and external requirements.
Responsibilities
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Develop internal and external R packages for clinical trial analysis ( ADaM, tables, figures, listings).
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Validate R packages.
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Building complex R-Shiny applications (animations, dashboards) to address clinical questions, EU JCA requirements, and decision-making.
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Lead implementation in R and train other Biostatistics team members.
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Conduct statistical programming work of clinical data using R.
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Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
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Create and/or validate all safety and efficacy study output requirements (e.g. ADaM, TLFs ) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF)
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Collaborates with peers and statisticians to ensure the quality and accuracy -thus submission readiness -of clinical data as required by authorities (i.e . SDTM, ADaM, tables, figures, listings , define.xml).
Requirements
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Strong experience in R programming for clinical trial data including developing and validating R packages from CRO or Pharmaceutical Industry.
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Strong programming skills in R/R Shiny
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Proven experience in applying R and R-Shiny for the analysis and reporting of clinical trials. Ability to reproduce statistical analysis using R.
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Strong skills in data visualization and data wrangling using R. Proficiency in using R packages for data exploration and visualization.
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Application of statistical methodology and concepts in clinical trial analysis. Experience with R-Shiny apps for data exploration.
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Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs.
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Ability to conduct statistical programming of clinical data using R , and create/validate safety and efficacy outputs (ADaM, TLFs) aligned with study documentation (protocol, SAP, aCRF).
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Exposure to Late Phase , Real-World Evidence (RWE) & Global Medical Affairs studies is highly desirable.