Senior Biostatistician - Remote

Overview

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

In Short

• Provide expert statistical input to Phase I-IV global clinical trials.
• Design clinical trials including protocol and sample size determination.
• Produce and review analysis and reporting deliverables.
• Create and QC study specifications for ADaM datasets.
• Statistical programming and QC of tables, listings, and figures.
• Ensure quality and timeliness of statistical deliverables.
• Lead statistical activities on allocated studies.
• Communicate statistical concepts effectively to non-statisticians.
• Mentor and train junior staff.
• Work in a home-based environment within specified countries.

Requirements

• Minimum of a Masters (M.Sc.) in Medical Statistics or equivalent.
• 5 years of experience in a CRO, including 1-2 years leading studies.
• Fluent in spoken and written English.
• Excellent SAS programming skills.
• Experience managing timelines and budgets of statistical activities.
• Strong communication skills.
• Good understanding of medical terminology and clinical trial methodology.
• Knowledge of CDISC requirements.
• Good awareness of statistical principles in clinical trials.
• Experience with Bayesian statistics is a plus.

Benefits

• Opportunity to be part of an innovative organization.
• Mentoring and training to develop skills in the clinical trials industry.
• Supportive team environment.
• Competitive employment package.