5 - 8 years

7 - 12 Lacs

Posted:3 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Responsible for preparation of PK and Statistical Analysis and Statistical reports (BA/BE and Phase 1) for various regulatory submissions.
  • Provide statistical input and sample size calculations during protocol design
  • Provide statistical/programming inputs for CRF design and review
  • Generate randomization lists
  • Prepare statistical analysis plans
  • Perform blinded statistical review to check for data discrepancies
  • Generate statistical analysis data sets
  • Develop programming requirements documents for SAS programmers
  • Perform data analysis and prepare statistical reports
  • Generate data listings, tables and graphs
  • Develop programs for quality control of analysis programs
  • Provide Stat training to SAS programmers and knowledge sharing to statisticians
  • Prepare integrated summaries of efficacy & safety and answer regulatory queries
  • Understand and comply with all SOPs
  • Preparation of appendices in eCTD format.
  • Responsible to respond the sponsor/ regulatory queries

Preferred candidate profile

The candidate should have minimum 5+yrs experience in BA/BE and Phase-1 studies.

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NAVITAS LIFE SCIENCES

Life Sciences, Biotechnology, Pharmaceuticals

Phoenix

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