Job Summary
A company is looking for a Senior Statistical Programmer, Early Stage Development and PK/PD Modeling and Simulation Consultant (Hybrid at PA/NJ).
Key Responsibilities
- Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures, and associated documentation
- Ensure programmatic traceability from data source to analysis/modeling result
- Support the development of programming standards to enable efficient and high-quality production of programming deliverables
Required Qualifications, Training, and Education
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus 5 years SAS programming experience in a clinical trial environment, or MS in the same fields plus 3 years SAS programming experience
- Programming expertise with clinical endpoint data and pharmacokinetic data
- Experience in CDISC SDTM and ADaM standards
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
- Ability to comprehend analysis plans and implement statistical methods not currently available through commercial software packages
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