FSP Principal Biostatistician, Study Powering and Design

Location: Home-based in the United States or Canada

Annual base pay: $96,400–$309,000

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Provide statistical support for pharmaceutical clinical trials in patients, including Phase 2/3 studies.
• Collaborate with multidisciplinary teams to define study objectives, timelines, and statistical approaches.
• Perform simulations, sample size calculations, and power analyses to optimize study designs.
• Author statistical analysis plans, analysis dataset and TLF specifications, and clinical study reports.
• Validate efficacy analysis datasets, tables, listings, and figures, while guiding statistical programmers on safety analyses.
• Interpret study results and support exploratory analyses, IND/NDA activities, and other regulatory submissions.

Requirements

• PhD in Statistics, Biostatistics, or a related field with 3+ years of industry experience, or MS with 5+ years of industry experience.
• At least 2 years of Phase 2/3 clinical trial experience and 3+ years supporting simulations, sample size, and power calculations.
• Proficiency in R or SAS and experience validating or programming ADaM datasets and TLFs.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH.
• Knowledge of FDA guidance, ICH GCP, ICH E9, estimands, and multiple imputation methods.
• Must work remotely from the United States or Canada.

Nice to have

• Experience supporting written communications with regulators.
• 1+ year of experience in the immunology therapeutic area.
• Experience with Bayesian methods.

Culture & Benefits

• Home-based remote work with flexible schedules and work-life balance.
• Collaboration with statistical, research, and cross-functional sponsor teams.
• Technical training and a tailored development curriculum.
• Research opportunities aligned with individual expertise and long-term engagement opportunities.
• Exposure to regulatory submissions and the development of new therapies.