Senior Biostatistical Researcher
5 days ago
CyDen, a leading UK-based health and beauty company, is seeking an experienced Biostatistician to join its Clinical Research team. We are dedicated to developing innovative electronic beauty products for global distribution under recognized brand names.
The successful candidate will specialize in statistical analysis and interpretation of clinical data across various therapeutic areas, primarily Intense Pulsed Light (IPL) hair removal technologies and skin wellness applications.
Key Responsibilities- Design, analyze, and interpret statistical data from clinical studies to ensure scientifically valid results supporting the development, safety, and efficacy of new therapies or medical products.
- Develop statistical analysis plans (SAPs) and methodologies, including sample size calculations, randomization, and endpoints tailored to IPL hair removal clinical trials.
- Conduct descriptive and inferential statistical analyses for clinical data to assess treatment efficacy, safety, and adverse events.
- Maintain data integrity and adherence to regulatory standards, including ISO 14155.
- Generate comprehensive statistical analysis reports for internal decision making, Final Study Report (FSR) conclusion, regulatory submissions, and scientific publication.
To be successful in this role, you should have:
- A Master's or PhD in Biostatistics, Statistics, Mathematics, or a related field.
- Minimum of 2-3 years' experience in biostatistics, preferably within clinical trials, medical device research, a pharmaceutical or biotech company, or clinical research organization (CRO).
- Proficiency in statistical software such as SPSS, SAS, R, Python.
- Familiarity with clinical data standards.
- Knowledge of regulatory requirements and statistical methodologies specific to medical device clinical trials.
We offer a competitive salary range of £45,000 - £65,000 per annum, depending on experience, plus benefits including 25 days' holiday plus Bank holidays rising to 28 with length of service, 5% Company pension contributions, Company sick pay, career development opportunities, Employee Assistance Programme, and Cycle to Work Scheme.
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