Senior Statistical Programmer

vor 4 Monaten

Frankfurt am Main, Deutschland Novasyte Vollzeit

Make a significant impact on clinical trial studies for a biopharma company. Be highly involved in sponsor-side programming activities including SDTM review, vendor oversight, ADaM/TLF programming, macro development, integrations and submission deliverables. IQVIA is hiring for a sponsor-dedicated (FSP) team as a Statistical Programmer, working fully within the sponsor environment.

**Requirements**:

- Bachelor's degree from reputable university preferably in science/ mathematics related fields
- Attained SAS® certification
- 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.
- Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes
- Minimum of 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.

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
- 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
- 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.

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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