Certara
Website:
certara.com
Job details:
Overview
About Certara
Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
Our goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.
This job entails interpretation of Clinical trials data across various therapeutic areas and actively contribute to the development of database products that support informed decision making at various stages of clinical development and post approval phases using modelling and simulation approaches. This job necessitates a profound knowledge of pharmacology and clinical research, experience in development/process of clinical databases for conducting systematic literature review and meta-analysis (pair wise, network and model based meta-analysis).
Responsibilities
- Play a key role in the development of clinical database products in various therapeutic areas like Metabolic & CV, Neuroscience, Autoimmune, Oncology, Respiratory etc., with a very high quality that support Meta-analysis (Pair wise, Network and Model based meta-analysis)
- Analyze and annotate the information pertaining to trial design, treatments, demographics and outcomes data (biomarker, clinical, safety and quality of life outcomes) for full time course from clinical literature (Journals, conference abstracts, Regulatory reviews etc.)
- Digitize the results from graphs for outcomes reported on linear, logarithmic and semi-log scales with precision
- Perform the above consistently with a very high quality
- Work with lead consultant, peer data analyst and Quality manager to understand and contribute to database rules, specifications and quality process
- Undergo relevant training programs (Statistics, R coding, Systematic literature review and Data analysis methods) and excel in these skill enhancement programs to grow in the organization ladder
Qualifications
- Masters in Pharmacology or Pharmaceutics (with relevant experience), Pharma D, Clinical Practice, Masters in Public Health and Epidemiology
- Minimum 1 year of experience in the areas of Information science, Systematic Literature review, Health-economics and public health sectors, pharmaceutical industry experience preferred
- Strong knowledge of Pharmacology and clinical research is a must
- Knowledge of clinical development and post approval phases, PICOS approach, trial designs, Pharma Industry data standards/ontologies
- Knowledge of statistics, data management tools like R is an added advantage
Skills & Abilities:
- Comfortable in a team environment and able to communicate with and collaborate with peer scientists
- Excellent interpersonal skills
- Strong learning skills to be able to support databases in multiple disease areas
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 orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.
Click on Apply to know more.
