Principal Epidemiologist

Cytel provides unrivaled biometrics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. In this role you will join our FSP department and will for our client, one of the top pharmaceutical companies.

As Principal Epidemiologist you will support or lead one or more studies in large pharma, with a focus on Neurology and Immunology (N&I), in particular Lupus and Myositis

You will contribute by:

• To evaluate target populations and products in real world settings across immunology indications throughout the product lifecycle, in particular in N&I rare indications and in development.
• To develop and implement integrated RWD strategic plans for assigned products within the therapeutic area through cross-functional collaboration.
• To lead the design, implementation and oversee of epidemiology/RWE studies (burden of disease, comparative effectiveness, safety, pregnancy studies, external controls, etc)
• To ensure that results are effectively communicated to key audiences, both internally and externally, to drive decision making.
• To develop study related scientific documents (protocol, reports, publications, responses to regulators) with full responsibility and little direction.
• To perform feasibilities with the aim of identification and assessment if RWD sources are fit-for-purpose for potential epidemiology/RWE/pharmaco-epidemiology studies.
• To develop in a timely manner and with high-quality epidemiological/RWE sections of regulatory documents, such as submissions, orphan drug designations, pediatric investigation plans, risk management plans, safety evaluation reports.
• To review and provide critical assessment from the epidemiological perspective into key regulatory documents, company publications, and non-interventional studies.
• To provide epidemiology/RWE methods input cross-functionally, in particular in innovative methods.
• To work collaboratively cross-functionally within the company and maintain/built external network.

What we're looking for:

• Preferably health background (MD, pharmacologist). Doctoral degree (e.g. PhD) and/or Master’s degree (e.g. MSc) in Epidemiology, Public Health or related field
• Strong 2-3 years  of experience in epidemiology within pharma, CROs, especially in development and with strong knowledge of medical and regulatory, in Europe, US and preferably other regions of the world.
• Strong experience in running epidemiology/RWE studies: lead, design, implementation, and oversee; protocol and report development for several audiences (e.g. regulatory, medical community); communication of results through publications.
• Experience with secondary use of data studies, including studies using healthcare claims and/or electronical Medical Record data sources, and registries.
• Experience in leading and run multi-country studies with strong communications skills. Collaborative, proactive working style, with ability to work independently.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• Ability to be flexible when priorities change and deal with ambiguity.

What’s in it for you:

• You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
• You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
• Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
• Work with and leverage the best and brightest minds in the industry