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Job Description

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 & Scientific Affairs (ESA) 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 or 100% remote.

Discover Impactful Work:

You will take the role of independent principal investigator/consultant of projects and be responsible for the management of all aspects of project delivery including delegating project management tasks to junior staff. This role will also take scientific responsibility for project completion, strategic consultation, and for use of best methods to address research needs.

A day in the Life:

In this role you will provide leadership and oversight of scientific responsibility for the design and implementation of de novo data collection studies (retrospective, prospective, and/or cross-sectional).

• Be scientifically responsible person for design and implementation of selected Non-interventional studies; conceptualize methodologically sound advanced study designs to meet project objectives and develop/supervise the development of study protocols, statistical analysis plans and study reports.
• Responsible for project completion and quality delivery
• Coordinate and delegate tasks to mid-level and junior staff.
• Lead interactions with clients in the pharmaceutical and medical device industries by providing epidemiological leadership.
• Review and finalize project deliverables and ensure study findings are valid and reliable.
• Have final budget, deliverable, and project timeline responsibility; identify scope expansion and need for amendments
• Contribute to abstracts and manuscripts as co-author and when possible, first author.
• Serve as consultant to other principal investigators or staff on other projects.
• Lead or participate in cross-functional task forces and organizational initiatives.
• Provide scientific leadership to PPD business teams.
• Supervise and act as a guide and mentor to the staff across PPD locations.
• Lead the growth in your area of responsibility. Direct other "non-billable" activities, e.g., participates to proposals, design conceptual approaches for proposals, supervise junior staff, contribute to business development, identify, and pursue business opportunities to bring in new projects.
• Travel (national and international) is expected.
• Possible managerial duties.
• Is client-facing client calls and is expected to be able to address questions posed directly to them about their work
• Responsible for scientific consultation and for use of best methods to address research needs.
• Contribute to critical thinking and innovation

Keys to Success:

Education

• MSc or PhD (Epidemiology or closely related field)

Experience

• Extensive experience in quantitative methods in health services research, with the focus on design of non-interventional studies and data analysis using observational retrospective and prospective data
• Experience with design of peri- or post-approval late phase interventional studies is not required but would be considered a plus.

Knowledge, Skills, Abilities

• Knowledge of drug development process and familiarity with international regulatory requirements.
• Advanced understanding of relevant methodology and statistics
• Deep understanding of healthcare research principles, knowledge of practical research implementation
• Solid understanding of MS Office software including Word, Excel and PowerPoint; ability to read and understand SAS/STATA output; working knowledge of data analysis software (e.g., SAS, Stata, R) a plus

Physical Requirements / Work Environment

We value 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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