Remote Position

Principal Biostatistician – FTE or Contract

🌍 Remote · United States 💼 Full-time

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:

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