Associate Director of SDTM Programming

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

May 23, 2025 - 10:50

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