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Stat Programmer 2
JOB DESCRIPTION
Job Profile: Senior Statistical Programmer
Functional Area
Statistical Programming
Education Requirements:
• Bachelor’s degree from reputable university preferably in science/ mathematics related fields
• Attained SAS® certification
Technical Skills Requirements
• Must have excellent knowledge of SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
• Capable of programming simple statistical procedures as per specifications provided by biostatistician.
• Must have excellent knowledge of CDISC standards (SDTM and ADaM)
• Thorough understanding of relational database components and theory.
• Excellent application development skills.
• Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting of analysis results.
• Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
Experience Requirements:
More than 5 + years of experience in Statistical Programming in pharmaceutical or medical devices industry
Desirable Requirements:
• Good verbal and written communication skills.
• Ability to work on multiple projects, plan, organize and prioritize activities.
Responsibilities:
At a minimum, following activities are required to be performed:
• Adherence to all department-specific and project standards and SOPs
• Perform all responsibilities associated with SAS® Programmer roles.
• Assist the Programmers of their team in their day-to-day activities.
• Act as an escalation point for Programmer.
• Communicate with the sponsor as needed to ensure high quality and on time deliverables
• Recommend and develop project standards
• Apply SAS® programming knowledge to solve problems related to non-routine situations
• Understand, own and author the programming specifications and database definitions
• Generate and QC summary tables, data listings and graphs for in-house analyses of study data or publications using SAS standard coding practices.
• Create/acquire tools to improve programming efficiency or quality Validate work of other programmers.
JOB DESCRIPTION – SENIOR STATISTICAL PROGRAMMER – IQVIA
• Create/review programming plan, specifications for datasets and TLFs. Conduct plausibility and completeness checks of programming output across each study.
• Lead and own identified opportunities of process improvement
• Identify, build, and validate SAS® Macros
• Contribute to activities in validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
• Contribute to development and implementation of programming standards and conventions.
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
• Support data queries from another functional group
• Other responsibilities as defined on ad-hoc basis by senior management.
Relationships & Interactions
• Clinical Data Manager
• Biostatisticians
• Medical Coders
Brief Details about Adam/TFL Role:
• Create/review programming plan, specifications for datasets and ADaM using SAS. Conduct plausibility and completeness checks of programming output across each study.
• Good Exposure and have worked on Define.xml and package creation, worked on Pinnacle reports
• Develop and validate on TLF’S without any support. should have good first-hand experience on Tables and Listings.
Graph’s experience is preferrable but not mandatory
• Contribute to activities in validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
Brief Details about SDTM Role:
• Create/review programming plan, specifications for datasets and SDTM using SAS. Conduct plausibility and completeness checks of programming output across each study.
• Exposure and have worked on CRF Annotation, Define.xml and package creation, worked on Pinnacle reports
• Contribute to activities in validation and implementation including Standard Reporting Systems, SAS macro utility programs and associated tools.
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