Statistical Programmer

3 weeks ago

Thane Maharashtra, India IQVIA Full time

Internal extrernal stakeholders project team members vendors Create SAS programs to generate derived analysis datasets and content for tables listings and figures Perform programming validation to ensure quality of analysis datasets and programming outputs Provides programming support for project teams including development of programming strategies standards specifications and programmed analysis Support the electronic submission preparation and review Reviews key planning documents e g statistical analysis plan data presentation plan data review plan to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements Assesses impact on programming activities Interacts with vendors regarding project standards programming conventions programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences GBDS deliverables by consistently applying standards and complying with regulatory requirements guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and or performs programming assignments with minimal supervision Support improvement initiatives Minimum Requirements Bachelors degree in statistics biostatistics mathematics computer science or life sciences required At least 3 years programming experience in industry recommended For US positions US military experience will be considered towards industry experience Demonstrated proficiency in using SAS R or other programming languages to produce derived analysis datasets and TFLs Understanding of clinical data structure e g CDISC standards and relational database Demonstrated skills in using software tools and applications e g MS office XML Demonstrated ability in the handling and processing of upstream data e g multiple data forms workflow eDC SDTM Demonstrated ability in providing outputs to meet downstream requirements e g ADaM Data Definition Table e-submission Have good understanding of regulatory industry and technology standards and requirements Have good knowledge of statistical terminology clinical tests medical terminology and protocol designs Demonstrated ability to work in a team environment with clinical team members Preferred Requirments Minimum of 3 years clinical statistical programming experience within pharmaceutical clinical development Knowledge of the drug development process clinical trial methodology statistics and familiarity with global regulatory requirements Experience in other software packages e g R Experience with the Linux operating system IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at

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