At a Glance
- Tasks: Lead statistical strategy in oncology drug development and influence key clinical decisions.
- Company: Global pharmaceutical organisation focused on innovative cancer treatments.
- Benefits: Competitive salary, remote work flexibility, and opportunities for professional growth.
- Other info: UK home-based role with quarterly office visits for team collaboration.
- Why this job: Make a real impact in oncology while collaborating with top experts in the field.
- Qualifications: MSc or PhD in Biostatistics with significant experience in clinical development and oncology.
The predicted salary is between 80000 - 100000 £ per year.
I'm partnering with a global pharmaceutical organisation seeking an experienced Oncology Biostatistician to join its development organisation at Associate Director or Director level. This is a highly strategic individual contributor position for a statistician who combines deep technical expertise with the ability to influence clinical development strategy, regulatory interactions, and cross-functional decision-making across the full drug development lifecycle. The hiring team is specifically looking for a statistical leader who can operate independently, provide scientific direction across multiple stakeholders, and remain hands-on with study design and methodology.
Key Responsibilities
- Define statistical strategy across clinical development programmes from early through late phase development
- Contribute to Target Product Profile (TPP) and Clinical Development Plan (CDP) development
- Serve as the lead statistical representative within cross-functional development teams
- Influence study design, endpoint strategy, interim analyses, and development decision-making
- Lead statistical input into regulatory interactions, briefing documents, submission strategies, and responses to health authority questions
- Support Go/No-Go decision frameworks using advanced statistical methodologies
- Design and oversee adaptive studies, simulations, modelling approaches, and innovative trial methodologies
- Provide strategic oversight of statistical deliverables across studies and submissions
- Present statistical recommendations and development strategies to senior leadership teams
- Collaborate closely with Clinical Development, Regulatory Affairs, Biometrics, Medical Affairs, Programming, Data Management, and external partners
- Mentor and guide statisticians across projects while driving best practice and scientific innovation
- Support biomarker, PK/PD, clinical and observational study programmes
- Contribute to publications, payer dossiers, regulatory submissions, and integrated evidence generation activities
Essential Requirements
- MSc or PhD in Biostatistics, Statistics, or a related quantitative discipline
- Significant experience within pharmaceutical development environments
- Oncology experience is mandatory
- Clinical Development experience is mandatory
- Regulatory submission experience is mandatory
- Experience supporting studies across multiple stages of drug development
- Strong understanding of clinical trial methodology and statistical strategy
- Experience working directly with cross-functional development teams
- Advanced knowledge of statistical methods applied to clinical and biomarker data
- SAS proficiency required
- R experience preferred
- Strong communication and stakeholder management skills
Ideal Background
- The successful candidate will typically bring experience in:
- Early and late phase clinical development
- Adaptive trial design
- Bayesian methodologies
- Simulation modelling
- Interim analyses and data monitoring strategies
- Registrational studies and regulatory interactions
- Clinical Development Plans and programme-level strategy
- Statistical leadership across complex global programmes
- Influencing development decisions without direct line management responsibility
Location: This role is UK home-based. The position requires attendance at the Surrey office approximately once per quarter. Candidates will also be required to attend the office on their first day to collect equipment.
Associate Director/Director Biostatistics employer: Planet Pharma
Join a leading global pharmaceutical organisation that values innovation and strategic thinking in the field of Oncology Biostatistics. With a strong commitment to employee development, this company offers a collaborative work culture where you can influence clinical strategies and contribute to groundbreaking drug development. Enjoy the flexibility of a UK home-based role with opportunities for mentorship and professional growth, all while being part of a team that prioritises scientific excellence and regulatory success.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director/Director Biostatistics
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We think you need these skills to ace Associate Director/Director Biostatistics
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Planet Pharma!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Planet Pharma that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Planet Pharma!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Planet Pharma, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Planet Pharma
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Planet Pharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Planet Pharma’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
