Principal Biostatistician

Location: Remote (US)

Salary: $175,000–$215,000 USD per year

Company

hirify.global provides clinical data services and the elluminate Clinical Data Cloud to help life sciences organizations accelerate clinical development and improve data-driven decision-making.

What you will do

• Provide statistical consulting for clinical trials and serve as study statistician when required.
• Develop, review, and finalize statistical analysis plans, randomization schedules, data specifications, and quality control plans.
• Analyze clinical trial data and support blinded data reviews, interim analyses, exploratory analyses, and post-hoc analyses.
• Develop SAS programs for analysis datasets, tables, listings, graphs, queries, and patient profile reports.
• Mentor statistical programmers, perform quality control and validation, and resolve reporting and analysis issues.
• Collaborate with clients, clinical teams, programmers, data managers, and regulatory reviewers.

Requirements

• Master's degree in statistics or biostatistics preferred.
• 10+ years of pharmaceutical or biotechnology industry experience, or equivalent statistical consulting and SAS programming experience.
• Strong experience in clinical study design, statistical analysis, sample size determination, and randomization schedules, including IVRS specifications.
• Strong knowledge of ICH, GCP, and 21 CFR Part 11 guidelines, including FDA and EMEA regulatory requirements.
• Experience developing statistical analysis reports and conducting analyses for blinded data reviews, interim analyses, and other trial deliverables.
• Excellent English communication skills required. Knowledge of coding dictionaries, CDISC, SDTM, and ADaM is also required.

Nice to have

• SAS certification.

Culture & Benefits

• Remote work within the US.
• People-first, inclusive culture focused on diversity and individual contributions.
• Opportunities for learning, growth, and continuous improvement.
• Recognition for remote work, company culture, vision, values, and work-life balance.
• Available as an FTE or contract engagement.