Research Scientist Evidera- Epidemiologist (fully remote) at Thermo Fisher Scientific in Raleigh, North Carolina

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



Thermo Fisher Scientific Inc. is a premier company that is dedicated to enabling our customers to make the world healthier, cleaner, and safer. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement. Together, we work to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.



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
  


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  Burden of disease, unmet needs
  


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  Treatment patterns and drug utilization
  


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  Healthcare resource utilization
  


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  Overall safety, incidence of adverse events of special interest
  


• 
  Effectiveness and comparative effectiveness data
  

Position Overview:



The Research Scientist will take the role of Scientific Oversight of projects and be responsible for overseeing 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.



Essential Duties and Responsibilities (other duties may be assigned):



The Research Scientist will bear scientific responsibility for the design and implementation of de novo primary data collection studies (retrospective, prospective, and/or cross-sectional).


In particular, the Research Scientist will:

• Be scientifically responsible person for design and implementation of selected non-interventional studies; conceptualize advanced study designs and develop/oversee the development of study protocols, statistical analysis plans and study reports. Responsible for project completion and quality delivery. Delegate coordination tasks to mid-level and junior staff.


• Closely collaborate with operational project lead and oversight director, as well as with biostatisticians and programmers.


• Lead interactions with clients in the pharmaceutical and medical device industries.


• 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


• Contributes to abstracts and manuscripts as co-author and when possible, first author.


• Serve as consultant to staff on other projects.


• Act as a guide and mentor to the staff across Evidera 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 within Evidera and bring in new projects.


• Travel (national and international) is expected.


• Possible managerial duties.

Consulting Expectations:

• Participates in client calls and is expected to be able to address questions posed directly to him/her about his/her work


• Responsible for scientific consultation and for 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 7-10 years relevant experience
  


• 
  Academic research health services or Pharma or CRO experience
  


• 
  Pregnancy registry experience a plus!
  


• Knowledge of drug development process and familiarity with international regulatory requirements.


• Broad experience in quantitative methods in RWE (real-world evidence), with the focus on epidemiology/pharmacoepidemiology, design of non-interventional studies and data analysis using observational retrospective and prospective data


• Very good understanding of relevant methodology and statistics


• Deep understanding of healthcare research principles, knowledge of practical research implementation


• Working knowledge of MS Office software; ability to read and understand SAS/STATA output; working knowledge of data analysis software (e.g., SAS, Stata, R) a plus


• Experience with post-marketing requirements and post-authorization safety studies, including pregnancy and/or lactation studies would be considered a plus.


• Experience with design of peri- or post-approval late phase interventional studies is not required but would be considered a plus.

Personal Skills & Competencies:

• Demonstrated ability to communicate and document information effectively in written English, including the ability to produce scientific reports, presentations, emails, and other written deliverables that are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience.


• Strong organizational, time-management, prioritization, and decision-making skills necessary to evaluate, plan and accomplish multiple work goals in a timely fashion.


• 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.


• Strong communication and interpersonal skills including the ability to quickly develop and sustain positive rapport with internal and external contacts in person, over the phone and by email.


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


• Delivers a positive internal/external client experience; listens and understand the client's needs, and recommends solutions


• Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues, and escalations.


• Leverages working relationships with customers and colleagues to quickly develop and sustain positive rapport, build strong connections, cooperation, and collaboration in person, over the phone and by email.


• Tailors and delivers high-level presentations to diverse audiences using a variety of communication delivery methods (e.g., written, electronic, oral, interpersonal).


• Makes independent, critical decisions based on relevant information. Applies solutions based on decisions in a timely manner.


• Helps others distinguish relevant from irrelevant information and resolves discrepancies.


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


• Receives and learns from feedback.


• Desire and ability to guide and coach junior-to mid-to levels of scientific staff.

Our 4i Values:



Integrity - Innovation - Intensity - Involvement


If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!


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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