Remote Director, Statistical Programming

Summary

Join Endpoint Clinical as a Director, Statistical Programming to lead statistical activities in support of clinical trials and IRT implementation. This player-coach role involves contributing to trial designs, authoring statistical sections of IRT requirements, preparing statistical analysis plans, and reviewing and interpreting the analysis of 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
• SAS Certification(s) are highly preferred
• 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
• Oversee the recruitment, training, and evaluation of the department
• 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