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Job Description

Senior Epidemiologist - RWE

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.

Team Overview

Evidera 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 factors

• Burden of disease, unmet needs

• Treatment patterns and drug utilization

• Healthcare resource utilization

• Overall safety, incidence of adverse events of special interest

• Effectiveness and comparative effectiveness data
  

Position 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 consulting

• Lead early client-facing interaction and development of strategies to maximize the potential for winning project work

• Understand the regulatory context for RWE and be able to advise clients to pursue the most plausible RWE strategies

• Maintain current and in-depth understanding of the overall RWE landscape and provide leadership with ongoing recommendations for positioning the team and offerings

• Collaborate on the development of innovative RWE solution-focused offerings

• Senior scientific oversight of studies

• Design 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 reports

• Responsible for the quality and on-time completion of scientific deliverables; ensure findings are valid and reliable

• Responsible for final budget, deliverable, and project timelines; identify scope expansion and need for amendments, as needed

• Oversee and delegate tasks to mid-level staff

• Serve as consultant to other principal investigators or staff on the other projects

• Serve as a subject matter expert in RWE Epidemiology to the broader PPD organization

• Mentor mid-level junior staff

• External and internal thought leadership

• Contribute to abstracts and manuscripts as co-author and when possible, first/senior author positions

• Make presentations at scientific meetings

• Contribute to PPDs position as a recognized leader in RWE generation and integration

• Business 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 projects
  

Consulting Expectations:

• Participates in client calls and addresses questions posed directly to them about their work

• Proactively 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 affairs

• Clinical development in biopharma/biotech (especially per- or post-approval late phase interventional studies)

• Medical device development

• Post-authorization drug/device safety, effectiveness, long-term follow-up

• HEOR/epidemiology/RWE

• 8+years of management experience, preferred

• Knowledge of drug development process/familiarity with international regulatory requirements for drugs and devices in both pre- and post-authorization context

• In-depth expertise and engagement in current global discourse around regulatory use of RWE is highly desirable

• Excellent understanding of core epidemiological study methodology and/or biostatistics

• Broad experience in quantitative methos in life-sciences research, focus on design and implementation of non-interventional and/or interventional studies

• Working 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 plus

• Analyze complex issues and evidence, identify cause-effect relationships, and generate effective solutions

• Experience presenting ideas to individuals and groups in a formal presentation setting

• Tailors 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.

Perks

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.