At a Glance
- Tasks: Join our R&D team to conduct statistical analyses for veterinary studies and pharmaceutical development.
- Company: Be part of a leading pharmaceutical company with over 50 years of global impact.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make a difference in clinical research while working with cutting-edge statistical methods and technologies.
- Qualifications: Must have a degree in statistics or related field and 5+ years of relevant experience.
- Other info: Work closely with regulatory agencies and ensure compliance with industry standards.
The predicted salary is between 48000 - 72000 £ per year.
With over 50 years in business, our client is one of Northern Irelands leading companies and an industry leader across the world in pharmaceutical development. This position within the R&D Department supports the clinical research team by conducting statistical analyses for veterinary clinical/pre-clinical studies and pharmaceutical development in compliance with GLP/GMP standards and regulatory guidelines. Key Responsibilities: Serve as a statistical advisor for pre-clinical, clinical, and pharmaceutical studies. Design and prepare Statistical Analysis Plans for study protocols. Analyse study data using regulatory-approved statistical methods, interpret results, and compile detailed reports with clear conclusions. Perform data mining, cleaning, and visualization to support study insights. Create and review programming specifications for dataset analysis. Author, review, and adhere to SOPs based on FDA, EMA, and VICH guidelines. Ensure compliance with regulatory and GLP requirements in statistical approaches. Provide technical support for new product development projects and assist in root cause analysis. Respond to regulatory agency queries, presenting statistical results for submissions. Maintain accurate project documentation to ensure audit readiness. Update team members on statistical progress, outcomes, and potential risks. What we are looking for; A relevant statistics, biostatistics, data science or maths degree (with statistical focus) At least 5 years expertise in statistical programming (e.g. SAS, R, Python or similar statistical programmes) At least 5 years experience in clinical/pre-clinical statistics to include development of protocol design, sample size calculation, sampling plan, statistical plan and modelling (including mixed modelling), ANOVA. Experience developing custom programming codes to generate summary tables, data listings, graphs and derived datasets as specified in statistical plan. Expertise in analysing large databases to support Clinical and Pharmaceutical research in new product development. Demonstrate understanding and use of Design of Experiments (DOE) principles to support Clinical, Pharmaceutical and Analytical Development Proven ability to provide on time deliverables in multiple projects at various stages of development, Proven ability to work effectively in a team environment and with minimal technical guidance If this sounds like an opportunity that could potentially be of interest to you, simply get in touch with Nathaniel Ferris by applying to this advertisement or giving me a call. Skills: data statistics pharmaceutical scientific
Senior Biostatistician employer: CPL
Contact Detail:
CPL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Biostatistician
✨Tip Number 1
Make sure to highlight your experience with statistical programming languages like SAS, R, or Python during your conversations. Being able to discuss specific projects where you've utilized these tools will demonstrate your expertise and make you stand out.
✨Tip Number 2
Familiarize yourself with GLP/GMP standards and regulatory guidelines relevant to the pharmaceutical industry. Showing that you understand these compliance requirements can set you apart as a candidate who is ready to hit the ground running.
✨Tip Number 3
Prepare to discuss your experience with Design of Experiments (DOE) principles. Be ready to provide examples of how you've applied these principles in past projects, as this knowledge is crucial for the role.
✨Tip Number 4
Network with professionals in the pharmaceutical development field. Engaging with others in the industry can provide insights into the company culture and expectations, which can be beneficial during interviews.
We think you need these skills to ace Senior Biostatistician
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and requirements. Tailor your application to highlight your relevant experience in statistical programming and clinical research.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in statistical programming and clinical/pre-clinical statistics. Provide specific examples of projects where you designed Statistical Analysis Plans or performed data analysis.
Showcase Technical Skills: Clearly list your proficiency in statistical programming languages such as SAS, R, or Python. Mention any custom programming codes you've developed and how they contributed to project outcomes.
Demonstrate Compliance Knowledge: Mention your understanding of GLP/GMP standards and regulatory guidelines. Highlight any experience you have with FDA, EMA, or VICH guidelines, as this will show your readiness for the role.
How to prepare for a job interview at CPL
✨Showcase Your Statistical Expertise
Be prepared to discuss your experience with statistical programming languages like SAS, R, or Python. Highlight specific projects where you applied these skills, especially in clinical or pre-clinical settings.
✨Understand Regulatory Guidelines
Familiarize yourself with GLP/GMP standards and regulatory guidelines such as FDA, EMA, and VICH. Be ready to explain how you've ensured compliance in your previous work.
✨Demonstrate Problem-Solving Skills
Prepare examples of how you've tackled complex statistical challenges in past projects. Discuss your approach to root cause analysis and how it contributed to successful outcomes.
✨Communicate Clearly and Effectively
Since you'll be compiling detailed reports and presenting results, practice explaining complex statistical concepts in simple terms. This will show your ability to communicate effectively with both technical and non-technical team members.