Senior Biostatistician (SAS)

TL;DR

Senior Biostatistician (SAS): Developing statistical analyses, randomization schedules, statistical analysis plans, and clinical trial reports for Phase 1–4 studies with an accent on clinical data, regulatory standards, and statistical programming. Focus on leading study programs, performing sample size calculations, supporting unblinded DSMB reviews, and solving complex statistical and drug development challenges.

Location: Remote within the UK; the listed location is London, England, United Kingdom.

Company

hirify.global is a data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission expertise.

What you will do

• Create randomization and kit schedules in collaboration with sponsors and drug supply teams.
• Develop statistical analysis plans and TLF shells for Phase 1–4 studies and integrated programs.
• Review ADaM datasets, TLFs, statistical methods, and clinical study report sections with programmers, sponsors, and medical writers.
• Perform sample size calculations and produce high-quality statistical analyses across different study designs.
• Lead projects, submissions, client meetings, timelines, scope, and resource estimation.
• Support Data Safety Monitoring Boards as an unblinded statistician and provide FDA- and ICH-aligned statistical input.

Requirements

• Degree in Biostatistics, Statistics, Mathematics, or a related discipline; a master’s or PhD is preferred.
• At least 5 years of experience in biostatistics or a similar field.
• Strong SAS programming experience, including SAS Base and SAS macros.
• Thorough knowledge of clinical data, TLG production, CDISC, SDTM, and ADaM.
• Knowledge of clinical trial and pharmaceutical development, FDA, GCP, and 21 CFR Part 11 requirements.
• Excellent scientific writing, communication, organization, problem-solving, and collaboration skills.

Culture & Benefits

• Remote work arrangement within the UK.
• Supportive, collaborative, and inclusive working environment.
• Opportunity to work across pharmaceutical, biotech, and medical device clinical research projects.
• Exposure to international clinical research projects through a global organization operating across four continents.
• Great Place to Work certification and strong employee retention.