Overview
About Certara
Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies
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 1-2 years 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
