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RWE Study Data Management Lead

8 - 12 years

0 Lacs

Mumbai Maharashtra India

Posted:1 month ago| Platform: Linkedin logo

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Skills Required

data management design analysis ehr score regression compliance support development

Work Mode

On-site

Job Type

Full Time

Job Description

Pharmacovigilance!!!

Mumbai

8 to 12 Years

Any Life Science Graduate

babeeta.shahi@tcs.com


Roles & Responsibilities

  • Design and execute statistical analysis plans for RWE studies using data from electronic health records (EHR), claims databases, registries, and patient-reported outcomes.
  • Collaborate with cross-functional teams including epidemiologists, data scientists, medical writers, and regulatory experts.
  • Develop and validate statistical models (e.g., propensity score matching, survival analysis, regression models).
  • Ensure compliance with regulatory standards and guidelines (e.g., ICH, GPP, GDPR).
  • Interpret and communicate results to internal stakeholders and external partners.
  • Contribute to publications, conference presentations, and regulatory submissions.
  • Support the development of protocols, SAPs, and technical documentation.

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