Associate - Pharmacometrics - Chennai, India - Pfizer

Pfizer
Pfizer
Verified Company
Chennai, India

1 month ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
Position Purpose

  • 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 datarequest 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 analysisready 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, exposureresponse
modeling, model based meta-analysis (MBMA), quantitative methodology and best
practices, pharmacometrics tools, software, hardware, and related business processes.

Organizational Relationships

  • Reports to Pharmacometrics Colleague within the line organization of Pharmacometrics, Clinical
Pharmacology and Bioanalytics.

  • Matrixed relationships particularly with Pharmacometrics MBMA Group Lead, Clinical
Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and
other groups as required.

Primary Duties

  • 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

Training, Education and Experience

  • Experience with programming languages such as R (preferred) or SAS or MATLAB or Python required. Must be quantitatively inclined.
  • Knowledge of Statistics, Drugdevelopment will be preferred. Must be interested to work with clinical, medical and biological information.
  • Good communication skills (written, oral presentation)

Preferred Qualifications:

  • Other relevant software experience (e.g., Microsoft Excel and Word
  • We encourage applicants from different disciplines including clinical pharmacology, engineering biostatistics, medicine, biology, etc.

Work Location Assignment:
On Premise


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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