Senior Biostatistician
We are seeking an experienced Senior Biostatistician to provide statistical leadership across clinical development programs. This role offers the opportunity to work closely with senior clinical, scientific, and operational stakeholders, supporting the design, analysis, interpretation, and reporting of clinical studies while ensuring compliance with regulatory requirements and industry standards.
The successful candidate will play a key role in delivering robust statistical strategies that support clinical development decision-making, regulatory submissions, and overall program success.
Reporting to: Director, Clinical Affairs
Contract Type: 12-Month Fixed-Term Contract
Location: United Kingdom (Hybrid Working - minimum 3 days per week in the office)
Travel: Occasional travel may be required.
Key Responsibilities
Clinical Study Delivery
- Lead the statistical design and methodology of clinical trials, including endpoint selection and sample size determination.
- Provide statistical input into study protocols, case report forms (CRFs), and data collection methodologies.
- Develop, review, and implement Statistical Analysis Plans (SAPs).
- Prepare and review statistical sections of study synopses, protocols, clinical study reports, and regulatory documentation.
- Collaborate closely with clinical operations, data management, and cross-functional study teams to maintain data quality and study integrity.
- Conduct and oversee statistical analyses using appropriate methods, including regression modelling, survival analysis, Bayesian techniques, and other advanced methodologies where applicable.
- Interpret study data and communicate key findings to both technical and non-technical stakeholders.
- Ensure the accuracy, quality, and regulatory compliance of all statistical deliverables.
- Support regulatory submissions, integrated analyses, and responses to health authority queries.
- Participate in safety review meetings, data monitoring activities, and governance committees as required.
- Ensure compliance with ICH guidelines, GCP requirements, and internal quality standards.
Program and Department Support
- Contribute to process improvement initiatives and the modernization of clinical research practices.
- Support the development and revision of Standard Operating Procedures (SOPs).
- Share statistical expertise across the broader Clinical Affairs organization.
- Stay current with developments in biostatistics, clinical research methodology, and regulatory requirements.
- Deliver training and knowledge-sharing sessions where appropriate.
- Support additional Clinical Affairs projects and initiatives as required.
Candidate Profile
Education
- MSc or PhD in Statistics, Biostatistics, Mathematics, or a related quantitative discipline.
Experience
- 5+ years' experience in biostatistics within the pharmaceutical, biotechnology, or CRO sectors.
- Demonstrated experience supporting clinical trials across multiple development phases.
- Experience contributing to regulatory submissions and interactions with health authorities is highly desirable.
- Strong understanding of ICH-GCP and clinical research regulations.
Technical Skills
- Strong statistical programming skills using SAS and/or R.
- Experience with data visualization and statistical reporting.
- Thorough understanding of clinical trial design, analysis, and interpretation.
- Familiarity with CDISC standards, including SDTM and ADaM.
- Knowledge of advanced statistical methods such as adaptive trial designs, real-world evidence analyses, or machine learning applications is advantageous.
Personal Attributes
- Strong analytical and problem-solving capabilities.
- Excellent communication skills with the ability to explain complex statistical concepts clearly.
- Ability to lead projects and work effectively within multidisciplinary teams.
- High attention to detail and commitment to quality and scientific excellence.
What's on Offer
- Competitive salary and comprehensive benefits package.
- Opportunity to play a key role in the development of innovative therapies that can significantly improve patients' lives.
- Exposure to senior stakeholders and strategic decision-making.
- Collaboration with highly experienced scientific and clinical professionals.
- A dynamic and growing environment that combines scientific innovation with commercial success.
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