Principal Biostatistician (Medtech)

TL;DR

Principal Biostatistician (Medtech): Providing high-level consulting services for statistical analysis, reporting, and programming for clinical trials with an accent on protocol development and statistical analysis plans. Focus on validating programming outputs, developing randomization schedules, and ensuring strict compliance with ICH and FDA guidelines.

Location: Remote (Must be based in the USA)

Salary: $150,000 - $175,000 USD

Company

hirify.global provides the elluminate Clinical Data Cloud and expert data services to help life sciences organizations accelerate clinical development.

What you will do

• Provide expert consulting for statistical activities in clinical trials, acting as a primary study statistician.
• Develop, review, and finalize statistical analysis plans (SAP) and randomization schedules.
• Mentor statistical programmers and conduct quality control (QC) of their outputs and analysis data specifications.
• Develop SAS programs to generate analysis datasets (ADaM/SDTM) and trial-specific reporting, including tables, listings, and graphs.
• Collaborate with clinical teams for regulatory reviews, interim analyses, and blinded data reviews.
• Ensure all deliverables comply with hirify.global and industry quality standards.

Requirements

• 5+ years of experience in the Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming.
• Master's degree in Statistics, Biostatistics, or equivalent work experience.
• Strong knowledge of ICH, GCP, and 21 CFR Part 11 guidelines from FDA and EMEA.
• Proficiency in SAS programming and deep knowledge of CDISC data models (SDTM, ADaM).
• Experience in developing statistical designs for Phase I, II, and III clinical protocols.
• Excellent English proficiency (written and verbal).

Nice to have

• SAS certification.
• Proficiency in R, SPSS, or S-Plus.
• Experience with J-Review and Spotfire for data queries and analysis.
• Knowledge of PK data modeling.

Culture & Benefits

• Winner of the Top Workplaces USA Award for Remote Work.
• Culture Excellence Awards for vision, values, and work-life balance.
• Inclusive environment that values diversity and authentic self-expression.
• People-first organization dedicated to impacting the future of healthcare.
• Opportunities for continuous learning and professional growth.