At Thermo Fisher Scientific, you\xe2\x80\x99ll 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 \xe2\x80\x93 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\xe2\x80\x99 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\xe2\x80\x99 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 Epidemiologist (Senior Research Associate) leads the organization and management of research projects under the direction of senior staff. Day-to-day tasks include: drafts project deliverables and other study documents, interacts with clients and internal project team members, and contributes to critical thinking under the direction of senior staff. Supports scientific coordination and project management, including scoping, tracking progress, and coordinating team tasks for multiple projects.

A day in the Life:

The Senior Epidemiologist will lead and provide oversight on the design and implementation of de novo data collection studies (retrospective, prospective, and/or cross-sectional) under oversight of more senior staff.

• Provide scientific guidance/consultation on methodological and operational considerations of study design and conduct
• Lead or oversee the development of draft scientific project deliverables (e.g., protocols, case report forms (electronic or paper), statistical analysis plans, , reports) for senior review.
• Draft project deliverables (e.g., protocols, analysis plans, reports,) for senior review, and draft abstracts and manuscripts as lead or co-author.
• Directly contact study sponsors, physician guides, and clinical sites
• Assist the responsible scientist with monitoring project budget spend and managing timelines for scientific tasks/deliverables.
• Lead client-facing meeting and represents the project team.
• In some client engagements, serve as Principal Investigator, with final responsibilities for project budget, deliverables and timelines
• Contribute to the growth of PPD through business development activities, including support of proposal development, budget development and bid defense meetings; in some instances, leads proposal development and participates in bid defense meetings
• Participate in cross-functional task forces and organizational initiatives.
• Supervise and act as a guide and mentor to junior staff
• Support other organizational activities as needed (e.g., closely collaborate with other project collaborators such as clinical operations, data management, biostatistics, and data analysts; contribute to development of training materials and process improvements)
• Travel (national and international travel) is expected
• Is client-facing and is expected to be able to address questions posed directly to them about their work
• Demonstrate problem-solving skills by presenting to senior staff strategies to mitigate or address scientific and operational challenges.
• Contributes to critical thinking under the direction of senior staff.
• May possibly mentor or lead more junior staff or practice area interns

Keys to Success:

Education

• PhD or MSc (Epidemiology or closely related field) with 5 or more years of relevant experience

Experience

• Experience with de novo data collection (field) studies (non-interventional designs in particular) including quantitative methods in health services research
• Previous experience in consultancy and/or CRO environment highly desirable
• Experience with design of peri- or post-approval late phase interventional studies is not required but would be considered a plus

Knowledge, Skills, Abilities

• Good understanding of epidemiologic methodology and observational health research
• Demonstrated ability to communicate and document information effectively in written English, including the ability to produce well- organized and high-quality scientific reports, presentations, emails and other written deliverables; able to tailor documents based on the needs of the audience.
• Strong organizational, time-management, prioritization and decision-making skills necessary to evaluate, plan and implement multiple work goals in a timely fashion.
• Able to work independently and as a contributing team member and develop team members.
• Able to quickly learn and apply new information, skills and procedures.
• Proactive and positive approach to tasks and projects, as well as resilience when encountering process, project, budget or client changes that are inherent in the consulting environment.

Physical Requirements / Work Environment

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive and understand information & ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel.

#LI-REMOTE #LI-DU1 Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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