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\xc2\xae certification

Technical Skills Requirements

• Must have excellent knowledge of SAS\xc2\xae Base, and good knowledge of SAS\xc2\xae graph and SAS\xc2\xae 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\xc2\xae 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\xc2\xae 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\xc2\xae 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.

Graphs 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.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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