Biostatistician

4 weeks ago

sany, India Acme Services Private Limited Full time
JobDescription:
  • Experience of handling bioequivalence studie includingvarious study designs.
  • Calculate sample sizerequired for the study.
  • Generate randomizationschedule.
  • Estimate pharmacokinetic parametersand statistical analysis.
  • Perform statisticalanaly.ses and interpret the results.
  • Work onfive to six studies/work tasks simultaneously.
  • Define methodology of the clinical trialstudies.
  • Prepare and review the statisticalmethodolog/ sections(s) of study reports.
  • Prepare and review statistical analysis plan (SAP) tablesfigures and listings according to study design and regulatoryrequirement.
  • Preoare/review protocolsincluding study design sample size and statisticalmethodologies.
  • Development modification &validation of SAS programs as per requirement.
  • Develop and maintain statistical programs as necessary toperform analyses to prepare data displays and to verify dataaccuracy.
  • All statistical analysis performedusing SAS programs.
  • To ensure the complianceto GCP/GLP guidelines for the all statistical evolution.
  • Sound knowledge of regulatory guidance documents such asICHE3 and ICHE9.
  • Prepare and revision ofstandard operating procedure (SOPs) as per need and ensureimplementation.
  • Prioritize and coordinatebiostatistical support of assigned projects.

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