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- Tasks: Lead statistical strategies for a Phase III clinical trial and ensure data integrity.
- Company: Join a leading pharmaceutical company focused on innovative therapies.
- Benefits: Flexible hybrid work, competitive salary, and opportunities for professional growth.
- Why this job: Make a significant impact in clinical trials and advance your statistical expertise.
- Qualifications: 10+ years in pharma statistics with experience in late-phase clinical trials.
- Other info: Collaborative environment with a focus on regulatory excellence and team leadership.
The predicted salary is between 36000 - 60000 £ per year.
Title: Clinical Data Analyst Statistician
Note: This role goes beyond routine data analysis. The ideal candidate must possess deep expertise in clinical trial design, statistical methodologies, regulatory frameworks, and the practical implementation of statistical strategies within the pharmaceutical industry.
Project Overview:
The role involves the development and management of the comprehensive statistical approach for a Phase III clinical trial evaluating a new therapeutic indication for Lebrikizumab. The successful candidate will be responsible for ensuring the statistical integrity and scientific rigor of the trial by aligning design, analysis, and reporting with industry best practices and regulatory requirements.
Key Responsibilities:
- Lead and contribute to the creation of statistical plans and strategies, ensuring alignment with clinical objectives and regulatory standards.
- Provide expertise in dossier preparation, particularly across the full lifecycle of clinical studies (F1–F4), including study design, execution, analysis, and reporting.
- Apply advanced knowledge in clinical trial design, including defining protocols, developing statistical analysis plans (SAPs), creating shell tables, and determining estimands for study endpoints.
- Utilize statistical techniques to address complexities such as missing data, multiplicity adjustments, and other frequentist methods commonly applied in clinical trials.
- Perform simulations to support sample size estimation, power calculations, and scenario planning, ensuring robustness of statistical conclusions.
- Offer guidance on Bayesian methodologies as an advanced approach for data interpretation and adaptive trial designs.
- Collaborate with cross-functional teams, providing statistical consultation, training, and leadership to ensure data quality and consistency across all phases of the trial.
- Ensure adherence to ICH guidelines and other regulatory frameworks such as FDA and EMA requirements throughout the study lifecycle.
Qualifications:
- At least 10 years of experience working as a statistician within the pharmaceutical or biotech industry, with demonstrable contributions to late-phase clinical trials.
- Prior experience with dossier submissions and regulatory documents across F1–F4 studies.
- Strong background in defining and implementing clinical protocols, statistical analysis plans, and reporting frameworks.
- Proficiency in handling complex datasets, including missing data techniques, multiplicity corrections, and advanced modeling.
- Experience with simulations and scenario-based statistical planning.
- Knowledge of ICH guidelines and familiarity with global regulatory expectations.
- Experience in coordinating statistical teams and collaborating with clinical, data management, and regulatory departments.
- Exposure to Bayesian statistical approaches is highly desirable.
Work Arrangement:
This is a hybrid, part-time position offering flexibility, designed for candidates who can bring strategic statistical expertise to a high-impact clinical trial while working collaboratively across teams.
Senior Statistician employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Statistician
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the lookout for opportunities. Attend industry events or webinars to meet potential employers and showcase your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of clinical trial design and statistical methodologies. Be ready to discuss how you've tackled complex data challenges in the past, as this will show your depth of experience.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Use our website to find roles that match your skills, especially those involving advanced statistical techniques and regulatory frameworks.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to remind them of your fit for the role.
We think you need these skills to ace Senior Statistician
Some tips for your application 🫡
Show Off Your Expertise: Make sure to highlight your deep expertise in clinical trial design and statistical methodologies. We want to see how your experience aligns with the responsibilities of the role, especially in creating statistical plans and ensuring regulatory compliance.
Tailor Your Application: Don’t just send a generic CV and cover letter! Tailor your application to reflect the specific skills and experiences mentioned in the job description. We love seeing candidates who take the time to connect their background with what we’re looking for.
Be Clear and Concise: When writing your application, clarity is key. Use straightforward language to explain your past experiences and achievements. We appreciate well-structured applications that get straight to the point without unnecessary fluff.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at SRG
✨Know Your Stats Inside Out
Make sure you brush up on your statistical methodologies and clinical trial design. Be ready to discuss specific examples from your past experience, especially those that align with the responsibilities outlined in the job description. This will show that you not only understand the theory but can also apply it practically.
✨Familiarise Yourself with Regulatory Frameworks
Since this role involves adherence to ICH guidelines and regulatory requirements, it's crucial to demonstrate your knowledge of these frameworks. Prepare to discuss how you've navigated regulatory submissions in previous roles, particularly across F1–F4 studies, to showcase your expertise.
✨Prepare for Scenario-Based Questions
Expect questions that require you to think on your feet, especially around complex datasets and missing data techniques. Practise articulating your thought process for handling such scenarios, as this will highlight your problem-solving skills and ability to adapt statistical strategies in real-time.
✨Showcase Your Collaborative Spirit
This position requires collaboration with cross-functional teams, so be prepared to share examples of how you've successfully worked with clinical, data management, and regulatory departments. Highlight any leadership roles you've taken on and how you ensured data quality and consistency throughout the trial lifecycle.