At a Glance
- Tasks: Provide statistical expertise for clinical trials and support data analysis activities.
- Company: Join a leading diagnostics company focused on innovative healthcare solutions.
- Benefits: Competitive salary, professional development, and collaborative work environment.
- Other info: Dynamic team atmosphere with opportunities for growth in the healthcare sector.
- Why this job: Make a real impact in clinical research and contribute to groundbreaking medical advancements.
- Qualifications: BSc in a scientific discipline; MSc/PhD in statistics preferred with relevant experience.
The predicted salary is between 50000 - 65000 € per year.
Reporting to the Director of Biometrics, the Senior Statistician will be responsible for the provision of statistical expertise across clinical programs. This includes creation/review of statistical analysis plans, SAS® and R programming of descriptive and inferential analysis, and statistical support for the writing of clinical protocols and clinical study reports for Blue Earth Diagnostics sponsored/managed clinical trials. The Senior Statistician will also contribute scientific input concerning statistical approaches to be used in the design of clinical studies.
Main Responsibilities, Activities, Duties and Tasks
- Act as study statistician on assigned clinical studies as part of the project team.
- Support the oversight of biometrics vendors supporting Blue Earth Diagnostics sponsored/managed studies, including input into timelines, deliverables, and quality of vendor outputs.
- Provide statistical input and support into trial design and protocol development.
- Author/review statistical analysis plans.
- Review database setup documents in clinical study setup (e.g., Data Management Plan, Case Report Forms, Database Specifications, Edit Check Specifications).
- Support the data review in clinical studies (i.e., Tables/Figures/Listings, Clinical Data Interchange Standards Consortium (CDISC) data {Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)} and data submission packages {e.g., define.xml, Pinnacle21, Data Reviewer Guides}).
- Contribute to New Drug Application (NDA) / Market Authorisation Application (MAA) documentation, including review of clinical study reports.
- Coordinate closely with other functions including Medical, Clinical Operations, Imaging, and Regulatory Affairs.
- Other duties as determined by business needs.
Education
BSc (Hons) in mathematical or scientific discipline; post graduate degree (MSc/PhD) in statistical science.
Professional Experience, Knowledge & Technical Skills
- Demonstrated experience in application of statistical methods in clinical trials.
- Contributing to planning of data analysis activities in clinical trials, including data handling in electronic data capture platforms.
- Working with contract vendors supporting data management, programming, and statistical activities.
- Supporting regulatory submission activities, including data submission standards and contribution to NDA/MAA deliverables.
- In-depth understanding of CDISC Standards.
- In-depth understanding of the drug development process, including exposure to regulatory filings.
- Good understanding of SAS programming concepts, good programming practices and techniques related to drug development.
- Knowledge of Good Clinical Practice (GCP) regulations/requirements.
- Oncology and diagnostic imaging experience desirable.
Soft Skills – Company Values & Behaviours
- Ability to work in a high paced team environment, meet deadlines, & prioritise work on multiple projects.
- Ability to accurately estimate effort required for project related programming activities.
- Experience working within cross-functional and matrixed organizations.
- Excellent oral & written communication skills.
- Change mindset approach to wider working.
Senior Statistician in Banbury employer: Blue Earth Diagnostics
At Blue Earth Diagnostics, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through continuous professional development opportunities and the chance to work on cutting-edge clinical trials in a supportive environment. Located in a vibrant area, we offer competitive benefits and a dynamic team atmosphere that empowers our staff to make meaningful contributions to the field of oncology and diagnostic imaging.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Statistician in Banbury
✨Tip Number 1
Network like a pro! Reach out to professionals in the field of statistics and clinical trials. Attend industry events or webinars, and don’t be shy about connecting on LinkedIn. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methods and programming skills. Be ready to discuss your experience with SAS and R, and how you've applied these in clinical trials. Practice common interview questions and think of examples that showcase your expertise.
✨Tip Number 3
Showcase your soft skills! Employers love candidates who can communicate effectively and work well in teams. Be prepared to share examples of how you’ve collaborated with cross-functional teams and managed multiple projects under tight deadlines.
✨Tip Number 4
Don’t forget to apply through our website! We’re always looking for talented individuals like you. Keep an eye on our job postings and make sure your application stands out by highlighting your relevant experience and passion for the role.
We think you need these skills to ace Senior Statistician in Banbury
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Statistician role. Highlight your experience with statistical methods in clinical trials and any relevant programming skills, especially in SAS and R. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your skills can contribute to our team. Be specific about your experience with clinical study protocols and data analysis plans.
Showcase Your Soft Skills:Don’t forget to mention your soft skills! We value teamwork and communication, so share examples of how you've worked effectively in cross-functional teams or managed multiple projects under tight deadlines.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s straightforward and ensures your application goes directly to us. Plus, we love seeing candidates who take that extra step!
How to prepare for a job interview at Blue Earth Diagnostics
✨Know Your Stats
Brush up on your statistical methods and their application in clinical trials. Be ready to discuss specific examples from your past experience where you successfully applied these methods, especially in relation to SAS® and R programming.
✨Understand the Drug Development Process
Familiarise yourself with the entire drug development process, including regulatory submissions like NDA/MAA. This knowledge will help you demonstrate your understanding of how your role as a Senior Statistician fits into the bigger picture.
✨Prepare for Technical Questions
Expect technical questions related to CDISC standards and good programming practices. Prepare to explain your approach to data analysis activities and how you've handled data management in previous roles.
✨Showcase Your Soft Skills
Highlight your ability to work in a fast-paced team environment and manage multiple projects. Share examples of how you've effectively communicated with cross-functional teams and contributed to project success.
