Clinical Biostatistician

Job title:

Clinical Biostatistician

Company

Job description

CyDen 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 trials
• Conduct descriptive and inferential statistical analyses for clinical data to assess treatment efficacy, safety and adverse events
• Ensure 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
• Maintain 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/KPIsStatistical design and planningData analysisCollaboration with Clinical TeamsReport writing and interpretationQuality control and complianceContinuous improvementSkills, know-how experience:Must HaveEducation:Masters 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, PythonFamiliarity with clinical data standardsKnowledge of ANOVA, MANOVA, and regression modelsKnowledge of complex statistical methodologiesIdeal ExperienceKnowledge of regulatory requirements and statistical methodologies specific to medical device clinical trialsKnowledge of mixed-effect models is advantageousOther attributes:

• Strong analytical and problem-solving skills
• Excellent written and verbal communication
• Highly organised with excellent attention to detail
• Ability to work independently and manage multiple projects effectively

In return we offer competitive rates of pay, 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.CyDen is committed to being an equal opportunities employer and values diversity.

Expected salary

Location

Portsmouth

Job date

Tue, 12 Nov 2024 02:17:11 GMT

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