Study Design Statistician (Clinical Research)

TL;DR

Study Design Statistician (Biostatistics): Providing expert consultation on clinical trial design and executing statistical analysis for pharmaceutical and biotech clients with an accent on simulation and regulatory submission. Focus on developing Statistical Analysis Plans, implementing Bayesian approaches, and utilizing KerusCloud for trial simulation.

Location: Remote

Company

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

What you will do

• Lead the full life-cycle of statistical services and support for the KerusCloud simulation software.
• Prepare study protocols, Statistical Analysis Plans (SAP), and Statistical Analysis Reports (SAR).
• Summarize, analyze, and visualize study data using a variety of statistical methods.
• Provide statistical consultancy to sponsors throughout the full span of clinical development.
• Collaborate with the Product Development team to define key features and statistical aspects of KerusCloud.
• Support pre-sales discussions by identifying client needs and contributing to technical solutions and cost estimates.

Requirements

• Bachelor's degree in mathematics, statistics, physics, or pharmacology (Masters or PhD preferred).
• 5-7 years of experience in the application of medical statistics in pharma, CRO, or academic environments.
• Proficiency in SAS and/or R statistical software packages.
• Proven experience in delivering customer projects to high quality standards.
• Willingness to engage with clients to provide creative, business-oriented solutions.

Nice to have

• Experience in study design, protocol, and report writing.
• Expertise in modelling and simulation techniques to explore complex study designs.
• Experience with Bayesian approaches to the design and analysis of clinical data.
• Knowledge of early-phase drug development processes, including innovative and adaptive study designs.

Culture & Benefits

• Great Place to Work certified organization with an industry-best employee retention rate.
• Collaborative and inclusive work environment across a global footprint.
• Opportunity to work with state-of-the-art proprietary cloud-based trial simulation software.
• Supportive and innovative team culture where individual contributions truly matter.