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- Tasks: Lead statistical analysis for clinical studies and engage with regulatory bodies.
- Company: Join an innovative leader in clinical services and software solutions for life sciences.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in clinical research while working with cutting-edge technology and ethical practices.
- Qualifications: 10+ years in biostatistics, MSc or PhD required, with strong SAS programming skills.
- Other info: Opportunity to mentor new team members and contribute to impactful projects.
The predicted salary is between 54000 - 84000 £ per year.
My client, an emerging leader in Clinical services and software solutions for the life sciences industry, is looking for a Principal Biostatistician to join their team. They have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions to support clients in focusing on their core strengths.
The Principal Biostatistician, Clinical Data Systems and Services should possess robust statistical expertise, providing comprehensive support and analysis for clinical studies. Skilled in study design, reporting, and regulatory engagement, including FDA and EMEA communications. Experienced with CDISC standards, SAS proficiency, and DMC/DSMB support. Actively engage with clients and support sales through expert statistical solutions and SOP development.
ESSENTIAL DUTIES AND RESPONSIBILITIES- Possess a strong understanding of statistical principles and demonstrate strong statistical skills.
- Provide comprehensive statistical support throughout clinical studies.
- Conduct statistical analyses of clinical data and interpret the results, focusing on the efficiency and safety of drug molecules or study goals.
- Experienced in calculating sample sizes, developing concepts and protocols for studies, creating Statistical Analysis Plans (SAP), and preparing clinical study reports, including integrated summaries for regulatory submissions.
- Engage with regulatory bodies such as the FDA and EMEA, preparing statistical documentation and effectively communicating statistical plans and results in professional forums.
- Provide support for Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB), including charter development, SAP, and mock Tables, Listings, and Figures (TLFs) for DSMB support.
- Solid understanding and implementation of Clinical Data Interchange Standards Consortium (CDISC) requirements for regulatory submissions, including experience with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications generation and quality control of datasets.
- Extensive hands-on experience in statistical analysis using SAS, including creating mock shells for tables, listings, and figures (TLFs), and validating TLFs for New Drug Applications (NDA) and Biologics License Applications (BLA) submissions.
- Actively engage with clients to understand their statistical and analytical needs, providing expert advice and solutions.
- Support the sales cycle by contributing to proposals, presentations, and discussions that showcase our statistical capabilities and how they meet client requirements.
- Responsible for the creation and updating of Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions.
- 10+ years of experience as Biostatistician and working in a CRO/Pharma/Biotech company.
- 3+ years of experience in leading a team of biostatisticians and statistical programmers and working in a CRO/Pharma/Biotech company.
- MSc or PhD in Biostatistics or Statistics.
- Strong written and verbal communications skills, including proficiency in the English language with the ability to explain complex statistical concepts to non-statisticians.
- Proficient in statistical programming languages such as SAS, R, or Python.
- Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures, TLFs proficiency.
- Capable of directing and promoting teamwork in a multi-disciplinary team setting.
- Strong knowledge of regulatory guidelines and statistical methodology related to clinical development.
- Excellent written and verbal communications.
- Coach/mentor new team members to support efficient and quick onboarding.
- Cross-functional collaboration & Stakeholder management.
- Strong knowledge of ICH guidelines.
Contact Detail:
AL Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principle Biostatistician
✨Tip Number 1
Network with professionals in the clinical research and biostatistics fields. Attend industry conferences, webinars, or local meetups to connect with potential colleagues and learn about the latest trends and opportunities in the sector.
✨Tip Number 2
Showcase your expertise in SAS and CDISC standards through practical examples. If you have experience with specific projects or case studies, be prepared to discuss these in detail during interviews to demonstrate your hands-on skills.
✨Tip Number 3
Familiarise yourself with the company's recent projects and publications. Understanding their focus areas and challenges will allow you to tailor your discussions and show how your skills can directly contribute to their goals.
✨Tip Number 4
Prepare for potential technical interviews by brushing up on statistical methodologies and regulatory guidelines. Be ready to explain complex concepts clearly, as communication is key in this role, especially when engaging with clients and regulatory bodies.
We think you need these skills to ace Principle Biostatistician
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in biostatistics, particularly in clinical studies. Emphasise your expertise with CDISC standards, SAS proficiency, and any leadership roles you've held.
Craft a Compelling Cover Letter: In your cover letter, explain why you're passionate about the role of Principal Biostatistician. Mention specific projects or experiences that demonstrate your statistical skills and your ability to engage with regulatory bodies like the FDA and EMEA.
Showcase Your Communication Skills: Since strong communication is essential for this role, provide examples in your application of how you've effectively communicated complex statistical concepts to non-statisticians. This could be through presentations, reports, or team collaborations.
Highlight Leadership Experience: If you have experience leading teams of biostatisticians or statistical programmers, make sure to highlight this in your application. Discuss your approach to mentoring and promoting teamwork within a multi-disciplinary setting.
How to prepare for a job interview at AL Solutions
✨Showcase Your Statistical Expertise
Be prepared to discuss your experience with statistical principles and methodologies. Highlight specific projects where you applied your skills in study design, sample size calculations, and statistical analysis, especially in the context of clinical trials.
✨Familiarise Yourself with Regulatory Standards
Understand the key regulatory bodies like the FDA and EMEA, and be ready to talk about your experience in preparing statistical documentation for regulatory submissions. Mention any direct interactions you've had with these agencies.
✨Demonstrate Communication Skills
Since you'll need to explain complex statistical concepts to non-statisticians, practice articulating your thoughts clearly and concisely. Prepare examples of how you've successfully communicated statistical findings to diverse audiences.
✨Engage with Client Needs
Prepare to discuss how you've engaged with clients in the past to understand their statistical needs. Think of examples where your input directly contributed to successful proposals or presentations that showcased your statistical capabilities.
