2 - 7 years

4 - 8 Lacs

Posted:17 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Provide inputs in relevant sections during protocol development, sample size calculation and randomization for clinical trials and BA/BE studies.
  • Inputs for development of Protocol and/or statistical analysis plan.
  • Preparing tables, figures, listings; its mock shells and s/w workflow.
  • Carryout Statistical analysis using Pharmacokinetic and SAS programming using Statistical analysis software (e.g., WinNonlin and SAS®) for BA/BE.
  • Develop Statistical Analysis and Clinical Study Report for Statistical &/or pharmacokinetic aspects.
  • Interact with CROs towards monitoring/reviewing statistical deliverables.
  • Prepare response against statistical queries from regulatory agencies on dossier submitted.
  • Ability to develop the procedures, programs or prepare documents applicable to the general or project-related bio-statistical activities.
  • Support departmental activities to prepare SOPs & carryout QC.

Prepare/review raw data XPT files

Preferred candidate profile

Qualification : M.Sc (Statistics) with 02-05 years of relevant experience

vilshashah@torrentpharma.com

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Torrent Pharmaceuticals logo
Torrent Pharmaceuticals

Pharmaceutical Manufacturing

Ahmedabad Gujarat

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