At a Glance
- Tasks: Lead statistical planning and analysis for clinical trials in a dynamic team environment.
- Company: Join IQVIA, a top player in clinical research and healthcare insights.
- Benefits: Enjoy remote work flexibility and a supportive corporate culture.
- Other info: Ideal for those passionate about biostatistics and clinical research.
- Why this job: Make a real impact on patient outcomes while developing your statistical expertise.
- Qualifications: Masters or PhD in Biostatistics with experience in regulatory submissions required.
The predicted salary is between 48000 - 72000 € per year.
Job Overview
As a Principal Biostatistician you will liaise with cross‑functional teams to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.
Key Responsibilities
Leadership
- Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company
- Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee
- Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication
- Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections
- Leading studies at an operational level
- Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures
- Consult on operational/statistical/therapeutic area topics
Knowledge Sharing
- Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses
- Performs as subject matter expert (SME)
Risk Management
- Identifies risks to project delivery and/or quality, leads in a way to minimize risks
- Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions
Lock and Unblinding Process
- Leads the database lock and unblinding process for the statistical team
- Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules)
Statistical Expertise
- Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports)
- Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data)
- Provide expert review of ADaM reviewers guide (ADRG) and metadata
- Perform senior biostatistical review (SBR)
- Produce or perform quality control review of sample size calculations for complex studies
Requirements
- Masters or PhD degree in Biostatistics or a related field with relevant experience within the life‑science industry
- Expert in a broad range of complex statistical methods that apply to Phase 2‑3 clinical trials
- Expert in strategically collaborating with clinical and drug development experts
- Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries
- In‑depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Strong working knowledge of SAS or R
- Excellent knowledge of CDISC Data Standards
- Superb communication and collaboration skills
- Independent and pro‑active problem‑solving skills
- Rare disease and immunology experience is greatly preferred.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Principal Biostatistician , FSP - Permanent Homebased (m/w/d) in Reading employer: IQVIA
IQVIA is an exceptional employer that fosters a collaborative and innovative work culture, allowing Principal Biostatisticians to thrive in a home-based environment. With a strong commitment to employee growth, IQVIA offers extensive training opportunities and encourages knowledge sharing among teams, ensuring that you remain at the forefront of biostatistical advancements. Additionally, working from Reading, UK, provides a unique advantage of being part of a vibrant community while contributing to impactful pharmaceutical developments that improve patient outcomes globally.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Biostatistician , FSP - Permanent Homebased (m/w/d) in Reading
✨Tip Number 1
Network with professionals in the biostatistics field, especially those who have experience with regulatory submissions. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends.
✨Tip Number 2
Familiarise yourself with the specific statistical methodologies used in Phase 2-3 trials. This will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your experience with SAS or R in detail. Be ready to provide examples of how you've applied these tools in previous projects, particularly in relation to clinical trial data analysis.
✨Tip Number 4
Stay updated on GCP and ICH guidelines, as well as any recent changes in clinical research regulations. This knowledge will be crucial in demonstrating your expertise and ensuring compliance in your work.
We think you need these skills to ace Principal Biostatistician , FSP - Permanent Homebased (m/w/d) in Reading
Some tips for your application 🫡
Understand the Role:Before applying, make sure you fully understand the responsibilities and requirements of the Principal Biostatistician position. Familiarise yourself with the key responsibilities such as statistical planning, analysis, and reporting in clinical trials.
Tailor Your CV:Customise your CV to highlight relevant experience in biostatistics, particularly in Phase 2-3 trials and regulatory submissions. Emphasise your expertise in SAS or R, and any experience with rare diseases or immunology.
Craft a Strong Cover Letter:Write a compelling cover letter that showcases your passion for biostatistics and your understanding of the pharmaceutical development process. Mention specific projects or experiences that align with the job description.
Highlight Communication Skills:Since excellent communication and collaboration skills are crucial for this role, provide examples in your application that demonstrate your ability to work effectively within cross-functional teams and engage with stakeholders.
How to prepare for a job interview at IQVIA
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid grasp of what a Principal Biostatistician does. Familiarise yourself with the key responsibilities listed in the job description, such as leading statistical analyses and ensuring regulatory compliance. This will help you articulate how your experience aligns with their needs.
✨Showcase Your Statistical Expertise
Be prepared to discuss your knowledge of complex statistical methods, particularly those relevant to Phase 2-3 trials. Highlight any specific experiences where you've applied these methods successfully, especially in regulatory submissions. This will demonstrate your capability and confidence in the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle real-world challenges. Think of examples from your past work where you identified risks or improved processes. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
✨Emphasise Communication and Collaboration Skills
As a Principal Biostatistician, you'll need to liaise with various teams. Be ready to discuss how you've successfully communicated complex statistical concepts to non-statistical stakeholders. Share examples of collaborative projects that highlight your teamwork and leadership abilities.
