FSP Principal Biostatistician, Study Powering and Design

Location: Home-based remote in the United States or Canada

Salary: $115,900–$243,900 annual base pay

Company

hirify.global is a global clinical research organization providing 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, primarily in Phase 2/3 studies.
• Perform simulations, sample size calculations, power calculations, and study design optimization.
• Author statistical analysis plans, analysis dataset specifications, and tables, listings, and figures specifications.
• Validate efficacy analysis datasets and tables, listings, and figures using R or SAS.
• Guide programmers and collaborate with Data Management, Clinical Development, Clinical Operations, and multidisciplinary project teams.
• Interpret study results, support exploratory analyses, clinical study reports, and IND/NDA and other regulatory activities.

Requirements

• PhD in Statistics, Biostatistics, or a related field with at least 3 years of industry experience, or an MS with at least 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 for statistical analyses.
• Experience validating and programming ADaM datasets and tables, listings, and figures.
• Experience with CDISC standards, including SDTM, ADaM, and CDASH, plus knowledge of FDA guidance, ICH GCP, and ICH E9.
• Strong understanding of estimands and multiple imputation methods, with the ability to work independently and communicate statistical concepts effectively.

Nice to have

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

Culture & Benefits

• Home-based remote work with flexible schedules and a focus on 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.