Senior Epidemiologist RWE

Work Schedule

Environmental Conditions

Job Description

Senior Epidemiologist RWE

At Thermo Fisher Scientific youll 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 lifechanging 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.

TheEpidemiology and Scientific Affairs team focuses on generating realworld evidence and supports biopharmaceutical companies throughout the product lifecycle from early prelaunch planning to launch and postmarketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries generate realworld evidence to demonstrate and support the value of their products. Through the generation of realworld data via the design implementation and analyses of observational/noninterventional studies we may provide key information such as:

• Incidence and prevalence of diseases and comorbidities 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 . 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 clientfacing 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 indepth 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 solutionfocused offerings

• Senior scientific oversight of studies

• Design and implementation of selected RWE/noninterventional 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 ontime 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 midlevel 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 midlevel junior staff

• External and internal thought leadership

• Contribute to abstracts and manuscripts as coauthor 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 nonbillable activities e.g. participate in proposals design conceptual approaches for proposals supervise midlevel 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 postapproval late phase interventional studies)

• Medical device development

• Postauthorization drug/device safety effectiveness longterm followup

• HEOR/epidemiology/RWE

• 8years of management experience preferred

• Knowledge of drug development process/familiarity with international regulatory requirements for and devices in both pre and postauthorization context

• Indepth 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 lifesciences research focus on design and implementation of noninterventional 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 causeeffect relationships and generate effective solutions

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

• Tailors and delivers highlevel 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 timemanagement prioritization and decisionmaking 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 highlevel presentations to diverse audiences.

• Ability to make independent critical decisions based on relevant information.

• Desire and ability to guide and coach junior to midlevel 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 forwardthinking 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 100000 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.