Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- 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 and lead a team of biostatisticians.
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. With experience and expertise in a diverse range of therapeutic areas and a focus on innovative, technology-enabled solutions, they support clients to focus 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.
Principle Biostatistician employer: AL Solutions
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 during interviews. Be prepared to discuss specific projects where you applied these skills, as this will demonstrate your hands-on experience and problem-solving abilities.
✨Tip Number 3
Familiarise yourself with the company's recent projects and case studies. Understanding their approach to clinical trials and how they leverage technology can help you tailor your discussions and show that you're genuinely interested in their work.
✨Tip Number 4
Prepare to discuss your leadership experience in managing teams of biostatisticians. Highlight your coaching and mentoring skills, as well as any successful collaborations you've led, to demonstrate your ability to drive team performance.
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 Technical Skills: Clearly outline your technical skills in statistical programming languages such as SAS, R, or Python. Provide examples of how you've used these skills in previous roles, especially in creating Statistical Analysis Plans and preparing clinical study reports.
Highlight Communication Abilities: Since strong communication skills are essential for this role, include examples of how you've effectively communicated complex statistical concepts to non-statisticians. This could be through presentations, proposals, or team collaborations.
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 successfully conducted statistical analyses, developed Statistical Analysis Plans (SAP), or engaged with regulatory bodies like the FDA and EMEA.
✨Demonstrate Your SAS Proficiency
Since SAS is a key requirement for this role, be ready to talk about your hands-on experience with it. Discuss any complex analyses you've performed, how you've created mock shells for tables, listings, and figures, and your approach to validating TLFs for regulatory submissions.
✨Engage in Client-Focused Discussions
Prepare to explain how you've previously engaged with clients to understand their statistical needs. Share examples of how you provided expert advice and contributed to proposals or presentations that showcased your statistical capabilities.
✨Highlight Leadership and Teamwork Skills
As a Principal Biostatistician, you'll likely lead a team. Be ready to discuss your experience in mentoring new team members, promoting teamwork, and collaborating across multi-disciplinary teams. Provide examples of how you've directed projects and supported team dynamics.
