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London, United Kingdom Thermo Fisher Scientific Full time

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

**Location/Division Specific Information**:
The Epidemiology & Strategic Affairs (ESA) Real-World Evidence (RWE) team within PPD combines epidemiology, outcomes research, biostatistics and statistical programming, and in order to support our clients in the pharmaceutical/ biotechnology/ medical device industries in building real-world evidence to demonstrate and support the clinical, economic and humanistic value of their products. We understand our clients’ needs and we support the design and conduct of real-world observational studies throughout the product development and lifecycle, from early pre-launch planning to launch and post-marketing management. Our passionate team works hard to address real-world research questions to help fill in the gaps of burden of disease and unmet needs, describe treatment patterns, drug utilization, and adherence, understand resource utilization and costs of care, identify risk factors on disease outcomes, and outline post-marketing effectiveness and safety through post-authorization safety studies and comparative effectiveness studies. We conceptualize sophisticated study designs and develop/oversee study documents such protocols, case report forms, statistical analysis plans, analysis interpretation and study reports.

Join our growing team of dedicated scientists where you will get to work on complex, engaging projects. Our focus is on advising our clients on their real-world evidence development plans, on de novo (field, primary) data collection studies such as single and multi-country retrospective chart reviews, surveys, prospective studies and registries, which are undertaken when existing healthcare databases cannot be used. Increasingly, hybrid studies that invoke the use of both secondary data sources with tailored data collection methods are deployed. We are constantly working on new and innovate solutions to address our clients’ needs. You would be joining a team of recognized industry guides who provide top methodological expertise and high levels of quality in a collaborative environment conducive to career growth. Whether you are looking to expand your knowledge and scientific skills or step into a leadership position, we are looking for a self-motivated, driven standout colleague who will thrive in this environment.

**Position Location**: Office-based, hybrid or 100% remote.

**Discover Impactful Work**:
The Senior Statistician provides statistical and programming expertise to the ESA Team through leadership in representing ESA statistical services, collaborations with other statistical teams across the organization, and project delivery, including Clinical Data Interchange Standards Consortium (CDISC) SDTM/ADaM standards as necessary, leading-development activities, business initiatives and long-term planning. This includes contributing to and driving -CDISC-based initiatives such as development of procedures, bidding templates, hiring, training and professional development.

When needed, the Senior Statistician will provide statistical as well as programming expertise. Responsibilities also include direct contributions to client proposals and study execution for the ESA business, including a variety of prospective and retrospective study designs. The Senior Statistician will be available to provide statistical consulting services across a variety of studies and study types and oversee and provide senior statistical review of statistical deliverables, as needed.

**A day in the Life**:

- Contributes to ESA project delivery model under SDTM/ADaM standards
- Assists in training of SDTM/ADaM standards to other statisticians and/or programmers
- Contributes to the preparation of study proposals and statistical budgets. Independently organizes, leads, or participates in business development presentations and represents the practice area at bid defenses.
- Acts as lead statistician, project lead, or programmer on ESA, consumer health and device projects and/or development programs
- Translates client’s objectives and demands into quantitative workplans
- Drives statistical and programming aspects of projects, including analysis plan writing, programming, and inte