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Associate Director of SDTM Programming
Job Summary
A company is looking for an Associate Director - SDTM programming.
Key Responsibilities
- Provide statistical programming technical support for project teams and ensure quality of SDTM and ADaM datasets and TFLs
- Support regulatory submissions and develop programming submission strategies, including integrated analysis and ad-hoc requests
- Develop and maintain programming standards and tools to improve efficiency and quality in clinical trial data analysis
Required Qualifications
- Bachelor's Degree in a science or technical field; Master's Degree preferred
- 10+ years of experience in the pharmaceutical industry or CROs related to statistical analysis of clinical trials
- Proven experience with SAS macro and system utility development preferred
- Advanced knowledge of CDISC SDTM and ADaM standards and their implementation in clinical trials
- Understanding of all phases of drug development and solid background in applied statistics preferred
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COMPLETE JOB DESCRIPTION
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