Senior Epidemiologist RWE

Job title:

Senior Epidemiologist RWE

Company:

Thermo Fisher Scientific

Job description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionSenior Epidemiologist – RWEAt 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.Team OverviewEvidera is a business within Pharmaceutical Product Development, LLC (PPD) a leading global contract research organization (CRO). We provide integrated scientific expertise and global operational capabilities to help clients generate the evidence needed to optimize the market access and commercial potential of products.The Epidemiology and Scientific Affairs team focuses on generating real-world evidence and supports biopharmaceutical companies throughout the product lifecycle, from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries generate real-world evidence to demonstrate and support the value of their products. Through the generation of real-world data via the design, implementation, and analyses of observational/non-interventional studies, we may provide key information such as:Incidence and prevalence of diseases and co-morbidities, and their risk factorsBurden of disease, unmet needsTreatment patterns and drug utilizationHealthcare resource utilizationOverall safety, incidence of adverse events of special interestEffectiveness and comparative effectiveness dataPosition Overview:The Senior Epidemiologist (Sr Research Scientist) serves as the person responsible for strategic consultation, client insights and consultative selling, innovative solution development, defining best methods to address research needs, and partnering with research operations leadership to ensure flowless project execution. The SRS will also be responsible for senior oversight of project design, protocol, and final study report development, including delegating tasks to staff and ensuring the quality and timeliness of scientific deliverables.Essential Duties and Responsibilities :Scientific strategy consultingLead early client-facing interaction and development of strategies to maximize the potential for winning project workUnderstand the regulatory context for RWE and be able to advise clients to pursue the most plausible RWE strategiesMaintain current and in-depth understanding of the overall RWE landscape and provide leadership with ongoing recommendations for positioning the team and offeringsCollaborate on the development of innovative RWE solution-focused offeringsSenior scientific oversight of studiesDesign and implementation of selected RWE/non-interventional study methods, conceptualize advanced study designs and develop/oversee the development of study protocols and statistical analysis plans and study reportsResponsible for the quality and on-time completion of scientific deliverables; ensure findings are valid and reliableResponsible for final budget, deliverable, and project timelines; identify scope expansion and need for amendments, as neededOversee and delegate tasks to mid-level staffServe as consultant to other principal investigators or staff on the other projectsServe as a subject matter expert in RWE Epidemiology to the broader PPD organizationMentor mid-level junior staffExternal and internal thought leadershipContribute to abstracts and manuscripts as co-author and when possible, first/senior author positionsMake presentations at scientific meetingsContribute to PPDs position as a recognized leader in RWE generation and integrationBusiness development and other “non-billable” activities, e.g., participate in proposals, design conceptual approaches for proposals, supervise mid-level staff, contribute to business development, identify and pursue business opportunities within PPD and bring in new projectsConsulting Expectations:Participates in client calls and addresses questions posed directly to them about their workProactively identifies issues and develops strategies for mitigation and/or effective solutions.Responsible for scientific consultation and for the use of best methods to address research needs.Contributes to strategic thinking and innovation.Education, Professional Skills & Experience:PhD (epidemiology or closely related field) or MSc with at least 15 years relevant experience in at least one (preferably more) of the following key areas:Medical affairsClinical development in biopharma/biotech (especially per- or post-approval late phase interventional studies)Medical device developmentPost-authorization drug/device safety, effectiveness, long-term follow-upHEOR/epidemiology/RWE8+years of management experience, preferredKnowledge of drug development process/familiarity with international regulatory requirements for drugs and devices in both pre- and post-authorization contextIn-depth expertise and engagement in current global discourse around regulatory use of RWE is highly desirableExcellent understanding of core epidemiological study methodology and/or biostatisticsBroad experience in quantitative methos in life-sciences research, focus on design and implementation of non-interventional and/or interventional studiesWorking knowledge of MS Office software; ability to read and understand SAS/STATA output; working knowledge of statistical analysis software (e.g., SAS, Stata, R) is a plusAnalyze complex issues and evidence, identify cause-effect relationships, and generate effective solutionsExperience presenting ideas to individuals and groups in a formal presentation settingTailors and delivers high-level presentations to diverse audiences using a variety of communication delivery methods (e.g., written electronic, oral, interpersonal)Personal Skills & Competencies:Excellent written and verbal communication skills in English.Strong organizational, time-management, prioritization, and decision-making skills.Ability to learn and apply new information, skills, and procedures quickly.Proactive and positive approach to tasks and projects.Strong interpersonal skills with the ability to develop and sustain positive rapport with internal and external contacts.Experience presenting ideas to individuals and groups.Sound professional judgment in analyzing, responding to, and resolving enquiries, issues, and escalations.Ability to tailor and deliver high-level presentations to diverse audiences.Ability to make independent, critical decisions based on relevant information.Desire and ability to guide and coach junior to mid-level scientific staff.PerksWe 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!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.

Expected salary

Location

United Kingdom

Job date

Tue, 15 Apr 2025 22:31:14 GMT

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