Clinical Biostatistician

CompanyCyDen is a British health and beauty company known for developing and manufacturing Intense Pulsed Light (IPL) hair removal devices for home use. Our innovative electronic beauty products are globally distributed across household and medical markets under widely recognized brand names. CyDen offers a dynamic, fast-paced environment with a supportive and welcoming team culture.We are seeking an experienced Biostatistician to join our Clinical Research team, specialising in the statistical analysis and interpretation of clinical data across our various therapeutic areas, primarily our Intense Pulsed Light (IPL) hair removal technologies, but also our skin wellness applications.In this role, you will design, analyse, and interpret statistical data from a range of clinical studies, supporting our commitment to safe, effective and evidence-based aesthetic solutions.This position offers a unique opportunity to be at the forefront of technological innovation in the aesthetic industry.Overall job purposeDesign, analyse, and interpret statistical data within clinical trials to ensure scientifically valid results that support the development, safety, and efficacy of new therapies or medical products.Collaborate with cross-functional teams to establish study protocols and determine statistical methodologiesCommunicate findings in reports, publications, and submissions.Key Responsibilities:Develop statistical analysis plans (SAPs) and methodologies, including sample size calculations, randomization, and endpoints tailored to IPL hair removal clinical trialsConduct descriptive and inferential statistical analyses for clinical data to assess treatment efficacy, safety and adverse eventsEnsure data integrity and adherence to regulatory standards including ISO 14155Generate comprehensive statistical analysis reports for internal decision making, Final Study Report (FSR) conclusion, regulatory submissions and scientific publicationMaintain best practices for data accuracy and compliance with regulatory guidelines, including FDA, ICH-GCP, ISO 14155.Stay current with advancements in biostatistical methods, clinical trial regulations, and IPL hair removal research to ensure innovative and robust trial designs. Key objectives/KPI’s·       Statistical design and planning·       Data analysis·       Collaboration with Clinical Teams·       Report writing and interpretation·       Quality control and compliance·       Continuous improvement                                                           Skills, know-how & experience:Must HaveEducation:·       Master’s or PhD. in Biostatistics, Statistics, Mathematics, or related fieldExperience:·       Minimum of 2-3 years in a biostatistics role, preferably within clinical trials, medical device research, a pharmaceutical or biotech company, or clinical research organisation (CRO).Technical Skills:·       Proficiency in statistical software such as SPSS, SAS, R, Python·       Familiarity with clinical data standards·       Knowledge of ANOVA, MANOVA, and regression models·       Knowledge of complex statistical methodologiesIdeal Experience·       Knowledge of regulatory requirements and statistical methodologies specific to medical device clinical trials·       Knowledge of mixed-effect models is advantageous  Other attributes:Strong analytical and problem-solving skillsExcellent written and verbal communicationHighly organised with excellent attention to detailAbility to work independently and manage multiple projects effectivelyIn return we offer competitive rates of pay, 25 days holiday plus Bank holidays rising to 30 with length of service, 5% Company pension contributions, Company sick pay, career development opportunities, Employee Assistance Programme and Cycle to Work Scheme.CyDen is committed to being an equal opportunities employer and values diversity.