at Certara USA, LLC in Wilmington, Delaware, United States
At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
informed decision-making & reduced clinical trial burden
higher R&D productivity
improved patient outcomes & increased patient access to medicines
accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
This is a great opportunity for an early career Epidemiologist/Pharmaco-Epidemiologist/Public Health professional to join a team of highly skilled epidemiologists, statisticians, health economists and consultants. The successful candidate will work closely with other senior scientific staff within the company. This position will allow the Senior Analyst/ Epidemiologist to deepen his/her skills by writing protocols for observational studies using a variety of healthcare databases, primary and secondary data collection, as well as providing scientific and other technical input during conception, conduct and delivery of various research projects.
Main tasks & responsibilities
Support Real World Data Solutions ( RWDS) project teams and be accountable to the project manager/director for those projects
Summarize and synthesize a wide range of medical and statistical information, including disease specific and pharmaceutical product research
Develop an understanding of Regulatory/HTA requirements for Real World Evidence (RWE), at least in the European and/or North American context
Support development of study documents (eg. protocols, analysis plans, reports, posters, manuscripts) under guidance from scientific team members and project manager/s
Liaise and manage processes with ethics committees, application committees and other relevant stakeholders to support acquisition of data for studies
Interpret and communicate the results of clinical/observational studies, health economic models (cost-effectiveness and budget impact) and statistical analyses
Undertake primary and secondary research initiatives including the retrieval and analysis of data, competitive product pipeline information, epidemiology trends, etc. according to needs of the project
Participates in production of reports, presentations and publications.
Critically analyzes data (presents results and provides internal data analysis, both qualitative and quantitative) and provides strategic thinking with respect to interpretation of results
Interact with and foster relationships with existing network of scientific/clinical/payer experts and data providers
Liaise with other consultants assigned to the project to ensure quality delivery of the project
Support senior personnel with activities required for business development from time to time
Align with and work within the framework of SOPs for data governance with respect to projects led
Required Qualifications / Experience
Minimum of Master's Degree in Epidemiology, Public Health, Medicine or other related field
At least 2 years relevant post-graduate work experience preferred
Professional proficiency in English, written and spoken
Experience designing/writing protocol for database or other observational studies
Ability to work both independently and as part of the team
Ability to effectively prioritize and manage multiple tasks and projects
This position can be office based or work-from-home in the UK, EU, Canada or USA.
Number of Employees Supervised: None
Percentage of Travel Required: 0-10% travel
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual... For full info follow application link.
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.