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Job Description
Job Overview:
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, clinical research, descriptive statistics and experience in development/process of clinical databases for conducting systematic literature review and meta-analysis (pair wise, network and model based meta-analysis)
Responsibilities
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
- Focus on standard ontologies like ICD-10, MedRA, CDISC, WHO, ATCC to develop database products in a consistent fashion
- Raise appropriate queries and special cases to set up the work flows
- Perform the above consistently with a very high quality and by meeting the productivity benchmarks
- 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
Education, Experience, Training, and Knowledge:
- Masters in Pharmacology or Pharmaceutics (with relevant experience), Pharma D, Clinical Practice, Master’s in Public Health and Epidemiology
- Basic understanding 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
- 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
Skills
ConsultantData AnalystData ManagementExcelQualityResearchStatisticsTrainingIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Certara is the global leader in biosimulation. Since 2014, our customers, who use our software and tech-enabled services, have received 90% of new drug
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