Job title: Data Analyst, Level 1

Company: Certara

Job description: Certara’s Better Drug Discovery and Development Process

The drug discovery and development process is long and expensive with more failures than successes. At

Certara, we anticipate and address critical drug discovery and development risks and decisions using biosimulation

and tech-enabled services.

Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using

quantitative methods to inform, guide, and supplant traditional development methods, will dramatically

improve efficiency, and reduce costs.

To achieve these objectives, Certara employs a strategic and programmatic approach that leverages its expertise

in drug development, clinical pharmacology, model-informed drug development (MIDD), health

economics/outcomes research (HEOR), real world evidence (RWE) services and regulatory science to optimize

end-to-end decision-making.

Model-based meta-analysis (MBMA) uses highly curated clinical trial data (Certara’s Clinical Trial Outcomes

Database Products) and pharmacology models to increase drug development productivity, quantitatively inform

portfolio management and improve clinical trial success offering three key advantages:

 supports bridging across studies, thereby enabling comparison of treatments and patient populations

that may never have been tested together in the same clinical trial.

 Our MBMA models are based on pharmacologic principles which facilitate incorporating wider

spectrum data with regard to dose, observation time, and clinical trial design.

 MBMA can be used to bring reality to synthetic patients and create synthetic control arms, offering

advantages to typical synthetic control arms based on observational data.

Certara’s data science team leverages over 20 years of experience exploring and analyzing publicly available

data for the world’s leading pharmaceutical companies to offer a library of analysis-ready Clinical Trial Outcomes

Databases in more than 50 therapeutic areas. These databases capture up-to-date information on trial design,

patient characteristics, treatments, statistical analyses, and results (efficacy/safety).

Our data science team are at the core of our model informed drug development and are:

 consultative with an ability to articulate process and expertise

 analytical oriented and innovative thinkers

 enthusiastic for continuous learning and application

 highly motivated offering time-driven solutions

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:

 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

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.

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Expected salary:

Location: Secunderabad, Telangana

Job date: Sat, 19 Mar 2022 08:41:24 GMT

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