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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 compliance and best practices.
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 datasets and regulatory requirements in past roles. We want you to shine!
✨Tip Number 3
Showcase your skills through practical examples. When discussing your experience, highlight specific projects where you led statistical strategies or contributed to successful dossier submissions. This will demonstrate your value to potential employers.
✨Tip Number 4
Don't forget to apply through our website! We have a range of exciting opportunities that match your skills. Plus, it’s a great way to ensure your application gets the attention it deserves.
We think you need these skills to ace Senior Statistician
Some tips for your application 🫡
Show Off Your Experience: When you're writing your application, make sure to highlight your 10+ years of experience in the pharmaceutical or biotech industry. We want to see how you've contributed to late-phase clinical trials and what specific roles you've played in dossier submissions and regulatory documents.
Be Specific About Your Skills: Don't just list your skills; give us examples! Talk about your expertise in clinical trial design, statistical methodologies, and how you've tackled complex datasets. We love seeing real-world applications of your knowledge, especially when it comes to ICH guidelines and Bayesian approaches.
Tailor Your Application: Make sure your application speaks directly to the role. Use the job description as a guide and align your experiences with the key responsibilities listed. This shows us that you understand what we're looking for and that you're genuinely interested in the position.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you get all the updates. Plus, it’s super easy to do!
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 be well-versed in these areas. Prepare to discuss how you've navigated regulatory submissions in previous roles, and be ready to explain how you ensure compliance throughout the study lifecycle.
✨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 demonstrate your problem-solving skills and ability to adapt statistical strategies in real-time.
✨Showcase Your Leadership Skills
This position requires collaboration with cross-functional teams, so be prepared to share examples of how you've led or contributed to team efforts in the past. Highlight your experience in providing statistical consultation and training, as well as how you’ve ensured data quality and consistency across projects.