Job Description:

• Provide statistical consulting for clinical trial activities and fulfill study statistician responsibilities
• Mentor and perform quality control of statistical programmers’ outputs and define analysis data specifications
• Interact with clients and clinical teams, including programmers, clinical data managers, and clinical protocol managers
• Develop, review, and finalize statistical analysis plans
• Validate programming deliverables and resolve statistical reporting and analysis issues
• Develop randomization schedules, specifications, and usage guidelines
• Contribute to study-specific data quality control plans and data analysis/reporting
• Develop, validate, and finalize tables and table shells for clinical study reports and study deliverables
• Ensure clinical team comments on statistical reports are appropriately addressed
• Analyze data and support trial progression decisions, including blinded data reviews and interim analyses
• Collaborate on regulatory reviews, representations, exploratory, ad-hoc, and post-hoc analyses
• Develop SAS programs for analysis datasets and clinical trial reporting, including tables, listings, graphs, queries, and patient profile reports
• Ensure compliance with company and industry quality standards, guidelines, and procedures
• Perform other duties as assigned

Requirements:

• Master in Statistics or biostatistics preferred
• SAS® certification preferred
• 10+ years in the pharmaceutical/biotechnology industry or equivalent statistical consulting and SAS programming role preferred
• Strong experience with clinical study design, analysis, and sample size determination
• Experience developing randomization schedules, IVRS specifications, and usage guidelines
• Excellent knowledge of English and clear, concise, accurate written and verbal communication
• Ability to multitask with strong prioritization, planning, and organization skills
• Ability and experience delegating tasks and leading projects
• Experience working on multiple clinical protocols simultaneously
• Ability to balance conflicting priorities
• Strong knowledge of ICH, GCP, and 21 CFR Part 11 guidelines, including FDA and EMEA requirements
• Experience developing statistical analysis reports and conducting statistical analyses for blinded data reviews and interim analyses
• Knowledge of coding dictionaries including WHO, COSTART, ICD-9, and MedDRA
• Knowledge of CDISC data models including SDTM and ADaM
• Ability to develop ADaM models for clinical trial analysis and reporting
• Thorough understanding of SDTM data structures

Benefits:

• Remote work
• Work-life balance
• Inclusive culture
• Professional development and career growth opportunities
• Equal opportunity employment
• Diversity-focused workplace