At a Glance
- Tasks: Lead statistical monitoring to enhance clinical study quality and patient outcomes.
- Company: Join Amgen, a pioneering biotech company dedicated to serving patients.
- Benefits: Enjoy competitive salary, comprehensive benefits, and flexible work options.
- Other info: Collaborative culture with opportunities for professional growth and development.
- Why this job: Make a real impact on patients' lives while advancing your career in biotech.
- Qualifications: Doctorate or Master's in Statistics or related field with relevant experience.
The predicted salary is between 70100 - 100000 £ per year.
Join Amgen’s Mission of Serving Patients. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do
In this vital role you will provide strategic, statistical, technical, operational, and business leadership for Centralized Statistical Monitoring (CSM). The role is accountable for the CSM analysis system, signal framework, statistical methodology, team leadership, cross‑functional delivery, and continued evolution of CSM as part of Amgen’s broader Risk‑Based Quality Management (RBQM) and study quality oversight strategy. The successful candidate will lead CSM capability development across a growing clinical portfolio, ensuring that CSM remains scientifically rigorous, scalable, inspection‑ready, and aligned with portfolio, regulatory, study team, and business needs. The role may also support related RBQM analytical needs, including Quality Tolerance Limit (QTL) approaches, where aligned with CSM scope and portfolio priorities.
Accountabilities
- Serve as the business owner for Amgen’s CSM analysis system, signal framework, and analytical workflows.
- Lead the strategy, roadmap, operating model, and continued evolution of the CSM capability in partnership with the Head of CSM / CfDA Safety and cross‑functional stakeholders.
- Provide leadership and accountability for the CSM Statistics team and statistical deliverables supporting the CSM capability.
- Advance conventional and innovative CSM methodology to support RBQM, Quality by Design, data quality, data integrity, and clinical study quality oversight.
- Prioritize CSM system enhancements, signal development, automation opportunities, and related RBQM analytical needs, including QTL approaches where aligned with CSM scope and portfolio priorities.
- Lead governance, documentation, inspection readiness, lifecycle management, and long‑term sustainability of the CSM capability.
- Serve as a senior point of accountability for CSM‑related questions, escalations, study team support, and cross‑functional alignment.
- Lead, coach, and develop CSM statisticians and supporting resources.
- Direct line management responsibilities may be in scope depending on the final operating model.
Key Responsibilities
- Lead the strategic development, operating model, roadmap, and continued evolution of Amgen’s Centralized Statistical Monitoring capability within the broader RBQM framework.
- Serve as business owner for the CSM analysis system, partnering with Digital Technology and Statistical Programming on requirements, prioritization, SDLC activities, business validation, UAT, release readiness, lifecycle management, and continuous improvement.
- Provide senior statistical and technical leadership for conventional and innovative CSM methodology, including signal development, site‑level analytics, anomaly detection, risk indicators, signal thresholds, QTL‑related approaches where applicable, and advanced statistical, machine learning, or AI‑enabled approaches where appropriate.
- Oversee statistical review, interpretation, documentation, and release of CSM signals across clinical studies, ensuring outputs are scientifically sound, traceable, inspection‑ready, and useful for study quality oversight.
- Partner with study teams, Global Statistical Leads, Global Development Operations, Data Management, Quality, RBQM, Digital Technology, and other stakeholders to support interpretation of CSM findings, issue escalation, and effective use of CSM outputs.
- Lead, coach, and develop CSM statisticians and supporting resources, including Amgen and Functional Service Provider resources as appropriate.
- Define and maintain CSM standards, guidance, training materials, operating procedures, and best practices to support consistent delivery, knowledge transfer, inspection readiness, and long‑term sustainability.
What we expect of you
The person we seek is a professional with these qualifications:
- Doctorate degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 8 years of relevant experience OR Master’s degree in Statistics, Biostatistics, Mathematics, Data Science, or a related quantitative discipline and 12 years of relevant experience.
- Significant statistical experience in the biopharmaceutical industry, including clinical development and clinical trial statistical oversight.
- Experience with Centralized Statistical Monitoring, RBQM, QTLs, Quality by Design, data integrity, or clinical trial quality oversight.
- Experience developing, evaluating, validating, or implementing statistical monitoring signals or regulated analytical deliverables in a production environment.
- Experience serving as a business owner, product owner, capability lead, or functional owner for an analytical, statistical, or clinical system, including SDLC activities such as requirements, UAT, business validation, release readiness, documentation, and lifecycle management.
- Strong statistical programming and analytical skills using SAS and/or R; Python experience a plus, with experience working with clinical trial, operational, EDC, metadata, or external data sources.
- Familiarity with Bayesian methods, hierarchical modeling, machine learning, advanced analytics, R Shiny, or business intelligence platforms.
- People management, functional leadership, coaching, or matrix leadership experience, including leading cross‑functional initiatives.
- Strong communication skills, global collaboration skills, and understanding of regulatory and industry trends relevant to RBQM, clinical trial quality, data integrity, and centralized monitoring.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Centralized Statistical Monitoring, Director employer: Amgen SA
Amgen is an exceptional employer dedicated to advancing healthcare through innovative biopharmaceutical solutions. With a collaborative and award-winning culture, employees are empowered to make a meaningful impact on patients' lives while enjoying comprehensive benefits, flexible work models, and ample opportunities for professional growth. Located in a vibrant area, Amgen fosters an environment where passion for science and commitment to patient care thrive together.
StudySmarter Expert Advice🤫
We think this is how you could land Centralized Statistical Monitoring, Director
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Amgen SA. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Amgen SA!
We think you need these skills to ace Centralized Statistical Monitoring, Director
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Amgen SA that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Amgen SA.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Amgen SA does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Amgen SA
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Amgen SA. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Amgen SA's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Amgen SA. This shows your passion for the industry!
