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Senior Biostatistician
2 weeks ago
Cambridge Cambridgeshire, United Kingdom
AL Solutions
Full time
George Higginson is currently searching for a highly experienced Senior Biostatistician for a clinical-stage Biotech, specialising in Dermatology/Rheumatology. They currently have x2 compounds in Phase 3 clinical trials. As a Senior Biostatistician, you are responsible for the oversight and management of biostatistics activities to ensure high quality design, analysis and interpretation of sponsored clinical trials. Main Responsibilities: - Statistical contribution to the design, analysis and interpretation of clinical studies, including the writing the statistical sections of protocols, SAPs and study related activities
- Oversight and review of vendor statistical activities, with accountability for study level timeliness and quality of statistical deliveries
- Act as key contact for biostatistics vendors to ensure effective communication between us and the biostatistics vendors
- Provide statistical insight and exploratory analyses of completed and ongoing studies
- Provide effective communication and visualisation of data and statistical analyses within our company and support for publications and presentations
- Communicate progress and identify risks and issues arising on clinical trials to the Director of Clinical Operations and other development team members as appropriate
- Postgraduate degree in statistics or related discipline
- Substantial experience of clinical biostatistics in the pharmaceutical/biotech industry
- Experience of managing outsourced biostatistics activities
- Experience in Dermatology/Rheumatology clinical trials would be an advantage
- Robust knowledge of GCP and related regulatory standards for clinical biostatistics governing clinical trials in the UK, EU & USA
- Programming experience with SAS and/or R
- Excellent oral and written communication skills
- Ability to interpret, process and present data in innovative ways to meet the needs of multiple stakeholders
- Highly organised, able to prioritise work, work well under pressure and meet deadlines Independent, self-starter with a proactive, problem-solving approach
- Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants
- Ability to see complex projects to completion, and to work on a broad range of tasks within a project
