Responsibility:

• 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.
• 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.
• 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 in 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 other functional group
• Other responsibilities as defined on ad-hoc basis by senior management.

Requirements:

minimum 5 years of experience on ADaM and TFL (SDTM experience is optional). Position is open for Oncology TA, so candidate should have Oncology experience working on ADTTE, ADRS, ADTU, ADTR datasets and KM Plots, Forest Plots, Swimmer lane plot, waterfall plot etc. Good understanding of RECIST Guidelines in Oncology is a must.

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