Clinical Biostatistician
Our client, a global diagnostics organisation are currently recruiting for a Clinical Biostatistician to join their team on a permanent basis. As Clinical Biostatistician you will be responsible for a wide range of advanced statistical expertise, guidance, and support to Clinical Affairs team engaged in R&D and Clinical studies.



Responsibilities

• Design, plan and execute biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of IVD products
• In development-phase projects, prepare the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards
• Develop and/or apply statistical theories, methods, and software
• Organize and interpret data into tabular forms amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used
• Provides specifications and directions to the clinical programmers
• May partner in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.

• Master's degree or equivalent experience preferred
• 4+ years of relevant work experience
• Experience with regulations and standards affecting the medical diagnostic industry
• Solid understanding of the clinical Research process with Good knowledge of EU and FDA regulatory requirements, as well as ICH/GCP guidelines is preferred
• Good Knowledge of statistical techniques and experimental design
• Proficient in SAS programming, preferably SAS certified. Solid understanding of the clinical Research process
• Ability to coordinate statistical activities for a clinical study
• Experience in CDISC standards with strong analytical and problem solving skills.
• Excellent organizational skills, detail-oriented, efficient and able to multi-task and prioritize
• effectively
• Excellent interpersonal skills with strong written and verbal communication skills