Certara

Overview

This job entails interpretation (analyzing and reviewing) 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 and quality management process of clinical databases for conducting systematic literature review and meta-analysis (pair wise, network and model based meta-analysis) and basic knowledge of information science (PICOS based literature search)

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 review 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.)
• The data extracted from graphs for outcomes reported on linear, logarithmic and semi-log scales with precision
• Perform the above consistently with a very high quality, provide the required feedback and training to the data analysts at L1/L2 continuously thereby contributing to the enhancement of database quality
• Review the literature search results, identify the miss cases and share the analysis report basing which the PICOS based search algorithm shall be enhanced (by lead consultant/Quality manager/Project Manager) to include the specific terms resulting in the miss cases
• Work with lead consultant, peer data analysts and Quality manager to understand and contribute to the database rules, meta-data management, specifications and quality enhancement on continuous basis to assure &ldquofirst time correctness&rdquo
• 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

Education, Experience, Training, and Knowledge:

• Masters in Pharmacology or Pharmaceutics (with relevant experience), Pharma D, Clinical Practice, Masters in Public Health and Epidemiology. PhD in Pharmaceutical sciences and MD Pharmacology are eligible with minimal/no work experience
• Minimum 2-4 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