Job Description

Overview:
Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees! As one of Certara's divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment. 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

Certara bases all employment-related decisions 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 characteristics protected by law.