Associate Director of Statistical Programming

A company is looking for an Associate Director of Statistical Programming. Key Responsibilities Lead programming work in the Statistical Programming Group, including the development and review of Statistical Analysis Plans (SAPs) and TLF shells Oversee the development of SDTM and ADaM dataset specifications and ensure compliance with regulations using CDISC validation software Mentor less experienced programmers and represent the Statistical Programming Group in cross-functional team meetings Required Qualifications 12-18 years of clinical trials experience BS in Mathematics, Statistics, or a related field preferred; MS/PhD in Biostatistics or Public Health preferred Expertise in SAS is required; experience with R or other statistical software is a plus Experience with electronic submissions in eDTC format and CDISC data standards (SDTM and ADaM) preferred Experience supporting Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) required

Apr 15, 2025 - 23:47
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Associate Director of Statistical Programming
A company is looking for an Associate Director of Statistical Programming. Key Responsibilities Lead programming work in the Statistical Programming Group, including the development and review of Statistical Analysis Plans (SAPs) and TLF shells Oversee the development of SDTM and ADaM dataset specifications and ensure compliance with regulations using CDISC validation software Mentor less experienced programmers and represent the Statistical Programming Group in cross-functional team meetings Required Qualifications 12-18 years of clinical trials experience BS in Mathematics, Statistics, or a related field preferred; MS/PhD in Biostatistics or Public Health preferred Expertise in SAS is required; experience with R or other statistical software is a plus Experience with electronic submissions in eDTC format and CDISC data standards (SDTM and ADaM) preferred Experience supporting Integrated Summary of Safety (ISS) or Integrated Summary of Efficacy (ISE) required