Principal Biostatistician
Il y a 6 mois
**Make your mark for patients**
**Principal Biostatistician (Safety)**
**About the Job**:
We’re looking for a Principal Biostatistician in Safety to join our Statistical Science and Innovation team. This individual has excellent communication skills and is able to communicate clear, accurate instructions in a non-technical manner to non-statisticians, represents the department internally and externally and fosters a culture of innovation. The Principal Biostatistician actively owns and drives the pragmatic use of innovative methods and serves as the statistical expert across functions globally in Safety Statistics.
**What you’ll do**:
***Safety Statistics**
- Lead the safety input to the project development teams, driving innovation and ensuring commitment to quality standards, processes and efficient delivery.
- Foster and encourage a culture of innovation, and act as a role model to others in actively owning and driving the pragmatic use of innovative methods where appropriate.
- Lead the development, introduction and maintenance of processes and methods relating to the analysis and reporting of safety data, including safety signal detection. In collaboration with CESI, evaluate innovative statistical methodology. Lead the development and maintenance of data visualization tools to aid evaluation of potential safety signals.
- Develop close collaboration with project statistical leads responsible for product development and other members of SSI where relevant, ensuring the required capabilities are assigned to deliver against the SSI support to the project to agreed.
- Acts as a resource for other biostatisticians in SSI and communicates complex issues in non technical language by using visuals, simulations and other illustrative techniques.
- Provides statistical sciences training to UCB employees from different disciplines on statistical concepts and seeks opportunity to represent UCB by active participation in external professional/technical forum and defend statistical strategy in front of regulatory authorities when required.
**Interested**? **For this position, you’ll need the following** **education, experience,** **and** **skills**:
5+ (with PhD) to 7+ (with Master’s degree) years in Biostatistics within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) or relevant academic role with proven successful track record in pharmaceutical development.
- Understanding of the Safety Signal Detection (SSD) process
- Understanding of safety reporting requirements and eCTD requirements including the Regulatory Authorities processes review and procedures).
- Experience in a variety of relevant statistical methodologies, including Bayesian approaches is preferred.
- Knowledge of SAS and/or R programming and experience with Phase 4 studies, Non-Interventional Studies (NIS) and registries is a plus.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you
**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
**Learn more** about sustainability at UCB and how it is integrated into our business approach.
UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.