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Pharmaceutical • Manufacturing
The Statistical Programmer is responsible for statistical programming, maintenance, and validation of datasets in clinical research, focusing on SDTM and ADaM. The role includes tasks such as data cleaning, use of SAS macros, and collaboration within biostatistical teams to ensure compliance with industry standards and timelines.
Top Skills:
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Healthtech • Information Technology • Security • Software • Cybersecurity
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Responsible for programming in SAS or other data analysis programming tools to process data from various sources and generate data reports to support clinical and pharmaceutical projects as well as medical research or Company analytical projects. The tasks will include creating variables, data extraction and manipulation, program debugging, as well as supporting statistical model implementation. Develop tools and techniques and perform periodic exploratory data analysis, program/process efficiency and quality assurance testing as required.
Project Support
- Provide data analysis support, develop programs using SAS or other data analysis programming tools, to generate and validate datasets, tables, listings and figures for clinical project reports and medical research, as well as working in conjunction with Statistician to program statistical tests as required when not available in SAS.
- Provide analytical programming support for Company projects.
- Regularly perform peer program quality reviews, identify gaps and/or errors in functionality, result quality and/or efficiency.
- Act as subject matter expert, provide advice and guidance to project teams and other stakeholders in the area of statistical programming support, development and testing.
Database Testing Reporting
- Create project database converting database sets, reviewing for variable attributes, testing, and validating database, reviewing, signing off and transferring of data from external sources ensuring data is received, validated and secure.
- Produce regular, accurate and user-friendly output discrepancies reports for stakeholders in accordance with project specifications.
Statistical Programming
- Develop data validation programs, provide data cleaning and validation solutions in accordance with project data requirements and specifications.
- Document, organize and maintain SAS macros program library, ensuring easy access for future use. Review, identify and where appropriate utilize existing SAS macro programs to improve efficiencies throughout the project life cycle.
Programming Support
- Assist other IT functions, administrative functions and/or clinical functions by providing ad hoc programming and reporting support and/or solutions where required and/or as assigned.
Qualifications
- A minimum of a College Diploma/Degree + 4-6 years of related experience + on-going job related training.
- Computer Sciences or Statistics specialty preferred.
Working Conditions
- Home-based.
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