Endpoint Clinical is hiring a
Director Statistical Programming

Summary

The job is for a Director of Statistical Programming in the life sciences industry. The role involves leading statistical activities in support of clinical trials, IRT implementation, and providing guidance to other departments. The position requires a Master's degree in Statistics or related fields and at least 8 years of experience in statistical programming, preferably in processing clinical trial data.

Requirements

• Masters of Science in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or related subject area is highly preferred
• Bachelor's in Computer Science, Engineering, or similar fields is required
• 8+ years of statistical programming experience, preferably in processing clinical trial data
• Experience in statistical programming languages and software such as SAS, R, and Python is required
• Prior experience in IRT platforms, life sciences, or regulated industries is highly preferred
• Knowledge of regulatory guidelines such as 21 CFR Part 11 and GxP
• Prior managerial experience is highly preferred

Responsibilities

• Identify, implement, and support process improvements and standard procedures within the Statistical Programming Group
• Lead, mentor, and manage the Statistical Programming team
• Drive innovation within the department by identifying and implementing new technologies and best practices
• Act as technical consultant to other departments
• Develop and maintain relationships with external partners, vendors, and stakeholders
• Consult with clients on statistical approaches as required
• Write, modify, and maintain statistical programs and macros that produce randomization files, data sets, tables, and listings for assigned projects
• Review study protocols and randomization requirements to create and verify randomization and kit lists
• Create programs that generate kit and randomization lists when appropriate
• Ensure the integrity of the randomization process within the IRT system
• Document and manage new and existing randomization lists
• Develop simulation programs to evaluate dynamic randomization models
• Review Statistical Analysis Plans and provide feedback to the author(s)
• Provide leadership, expertise, and guidance across delivery teams as required
• Perform other duties as required and assigned

Benefits

• Medical, Dental, Vision, Life, STD/LTD
• 401(K)
• Paid time off (PTO) or Flexible time off (FTO)
• Company bonus where applicable