Senior Biostatistician (Pharmaceuticals)

TL;DR

Senior Biostatistician (SAS/Clinical Trials): Developing and reviewing statistical analysis plans and ensuring consistency of clinical study protocols with an accent on regulatory submission challenges and complex trial data. Focus on performing senior-level reviews of datasets, generating sample size calculations, and coordinating the preparation of high-quality statistical analysis.

Location: Remote (UK)

Company

hirify.global is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with scientific approaches to trial data.

What you will do

• Develop and review statistical analysis plans (SAP) and provide advanced input into clinical study protocols.
• Perform senior-level reviews of datasets and outputs to ensure correctness, quality, and consistency with the SAP.
• Collaborate with programming teams to define analysis/ADaM datasets and prepare TLG specifications.
• Coordinate the execution, reporting, and documentation of high-quality statistical analysis.
• Prepare statistical methods and results sections for clinical study reports (CSR) in collaboration with medical writers.
• Provide support to Data Safety Monitoring Boards (DSMB) as an unblinded statistician.

Requirements

• Must be based in the UK.
• MS in Statistics (or equivalent) with 4+ years of experience, or PhD with 2+ years of experience.
• Strong hands-on proficiency with SAS (SAS Stat, Base, macros, ODS, Graph).
• Advanced knowledge of drug development statistical considerations and experience with clinical trial data.
• Strong expertise in study designs and methods (GLMs, survival analysis, non-parametric methods).
• At least 3 years of experience in the pharmaceutical industry and working knowledge of SDTM/ADaM standards.

Culture & Benefits

• Part of a Great Place to Work certified organization with an exceptional corporate culture.
• Industry-leading employee retention rate.
• Collaborative, inclusive, and supportive work environment.
• Opportunity to work within a global footprint across four continents.