Humaneva Group

Software Engineer

• Produce and coordinate SAS programs, outputs, and study reports for clinical trial programs
• Independently perform quality control on statistical outputs to achieve First Time Right outputs
• Function as study lead programmer and/or subject matter expert for complex studies
• Lead project assignments and programming teams as point of contact with Project Management and sponsor teams
• Maintain compliance with ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and company procedures
• Participate in project kick-off meetings to understand scope, plans, timelines, and project-specific requirements
• Develop and/or validate CDISC Data Standards specifications and programming for moderate-complex studies
• Develop and/or validate programming for integration of databases from multiple studies and sources
• Develop, validate, and document statistical programs for tables, figures, and listings
• Create or review Define packages (Define.xml) and Reviewer Guides for CDISC Data Standards
• Maintain, verify, and ensure quality and accuracy of assigned tasks
• Complete client-specific and organization-specific training documentation on time
• Forecast team workload and provide vision and clarity on project objectives, milestones, and upcoming projects
• Assist with SAS programs, macros, templates, and utilities for data cleaning and reporting
• Perform reconciliation of external data
• Provide advanced technical expertise with minimal supervision for clinical data analysis and reporting
• Mentor associates and support training for trainees and team members
• Provide process-improvement inputs to increase efficiency and align processes with regulatory and industry requirements
• Periodically evaluate team members and provide feedback
• Support internal or external audit requirements and quality/process improvement initiatives
• Perform other duties assigned by the Department Head or Immediate Supervisor

Lead Statistical Programmer

Clinical Research

• Serve as a trusted first point of contact for patients and provide professional support
• Coordinate and schedule patient appointments
• Ensure optimal appointment planning
• Maintain and manage patient data carefully and in compliance with data protection regulations
• Maintain and update patient lists
• Ensure structured data management
• Prepare expense compensation payments
• Support additional administrative tasks

Reception Specialist

General

• Review clinical trial contracts, study budgets, and payment terms and translate them into accurate financial setups
• Set up and maintain visit, procedure, start-up, administrative, and patient payment information
• Perform quality checks and reconcile financial data against contracts, budgets, and protocols
• Identify and resolve discrepancies, missing information, and data-quality issues
• Process contract amendments and budget changes, ensuring updates are accurately implemented and documented
• Work closely with Finance, Contracting, Clinical Operations, and Site Operations to clarify requirements and resolve issues
• Manage multiple studies, deadlines, and priorities while maintaining accurate documentation and following applicable procedures
• Contribute to financial processes supporting global clinical trials

Lead Statistical Programmer

Reception Specialist

Budget Setup Specialist