Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Sr. Associate - Pharmacometrics
Job Description
Job Summary
• Primarily responsible for liaising with Pharmacometrics (MBMA group) and clinical pharmacology therapeutic area leads in creating and maintaining up-to-date clinical literature databases and to provide data summaries and visualizations for clinical team reviews.
• Review data-request forms (PICOS), create literature searches and conduct manual as well as automated data extraction from scientific literature, conference abstracts, clinical databases etc., to generate curated data file (CDF) and development of a knowledge base for disease/therapeutic area,
• Document and report the effectiveness of the quality control checks and remediation performed and develop, maintain and report outcome of quality control metrics to demonstrate data curation and dataset construction quality improvement and maintenance goals and include the QC Form, QC Checklist, and QC Logs documentation on an indication-by-indication basis for each Final Draft
• May help provide support for creation and derivation of analysis-ready data sets, , conduct exploratory data analysis and visualization of literature and internal data to provide actionable insights to clinical teams to influence clinical trial design and decision making. May also help provide support for other pharmacometrics modeling such as population modeling, exposure-response modeling, model based meta-analysis (MBMA), quantitative methodology and best practices, pharmacometrics tools, software, hardware, and related business processes.
Job Responsibilities
• Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies
• Curate data from the Public Literature and Pfizer internal sources as necessary based upon the Pfizer Model Based Meta-Analysis (MBMA) Data Definition for assembly of CDFs
• Enhanced data extraction includes: Digitization of plots, Simple specified derivations
• Perform quality control checks on 100% of the curated data prior to final CDF delivery
• Identify and implement quality measures and systems.
• Create and provide mock/draft/sample CDFs and summary documentation to tabular and graphical presentations for review and comment by disease area team.
• Develop and generate Endpoint and Endpoint Subscale dictionaries producing a harmonized database of Endpoint Subscales in consultation with the MBMA Coordinator, maintaining the dictionaries in the approved MBMA repository. May contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
• Upon completion of provided training, conducts other pharmacometrics analysis such as population modeling and analysis, exposure-response analysis, model based meta-analysis (MBMA) clinical trial simulations and other analysis required to support clinical teams.
• Stays abreast of literature, government guidelines, and internal guidance as relates to modeling analysis including internal SOPs and regulations in order to be a team resource of pharmacometrics knowledge and applications.
Candidate Profile
• Bachelor's in pharmacy (B.Pharm), Science (B.Sc), Technology (B.Tech), Pharmaceutical Sciences or related disciplines with 0-4 years of experience (for Associate position), 3-4 years of experience (for Sr. Associate position) in quantitative data analysis skills, or Masters in above disciplines with 0-3 years of experience (Sr. Associate position) in quantitative data analysis.
• Some experience with programming language any of the languages such as R (preferred), SAS, MATLAB, C/C++ or Python is required. Must be quantitatively inclined.
• Knowledge of Statistics, Drug-development will be preferred. Must be interested to work with clinical, medical and biological information.
• Good communication skills (written, oral presentation)
• Other relevant software experience (e.g. Microsoft Excel and Word)
• We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc.
Additional Information
Experience : 0-4 years
Qualification : B.Pharm, B.Sc, B.Tech
Location : Chennai
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Pharmacometrics
End Date : 30th July, 2023
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