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: Fast-paced team environment with opportunities for career growth.
- 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 statistical science preferred.
The predicted salary is between 55000 - 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, & prioritize 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 Oxford 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 contribute to groundbreaking 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 a meaningful impact in the field of diagnostics.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Statistician in Oxford
✨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 introducing yourself. You never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your statistical knowledge and practical applications. Be ready to discuss your experience with SAS and R programming, as well as your contributions to clinical study designs. Show us you’re the expert we need!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Use our website to find roles that excite you, and tailor your approach to each one. We want to see your passion shine through!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to remind them why you’re the perfect fit for the Senior Statistician role.
We think you need these skills to ace Senior Statistician in Oxford
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 in SAS or 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. Don’t forget to mention your understanding of CDISC standards and regulatory submissions.
Showcase Your Soft Skills:We value teamwork and communication, so be sure to highlight your ability to work in a fast-paced environment and manage multiple projects. Share examples of how you've collaborated with cross-functional teams in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
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. Highlight any experience you have with NDA/MAA documentation and CDISC standards during the interview.
✨Showcase Your Teamwork Skills
Since this role involves working closely with various functions, be prepared to share examples of how you've collaborated in cross-functional teams. Emphasise your ability to meet deadlines and manage multiple projects simultaneously.
✨Prepare for Technical Questions
Expect technical questions related to statistical analysis plans and data management. Practice explaining complex concepts in a simple way, as clear communication is key in this role. Don't hesitate to ask clarifying questions if needed!
