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4 Statistical Modeling Jobs in Ahmedabad

General Manager - Bio Statistician

10-20 years

Ahmedabad

1 vacancy

General Manager - Bio Statistician

Morepen Laboratories

posted 27d ago

Job Description

Desired Experience


  • Experience of biostatistics in regulated markets
  • Interacted with regulatory agencies (FDA/EMA/PMDA)
  • Experience of biosimilar product development
  • Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis
  • Knowledge of using relevant software including PASS, SAS, SPSS, R

Job Description


  • Prepare scientifically sound statistical design for clinical trials
  • Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA)
  • Perform meta-analysis and calculate sample size
  • Prepare statistical justifications for agency interactions (FDA/EMA/PMDA)
  • Review and provide inputs to statistical sections of clinical trial protocol
  • Plan and perform blinded sample size re-estimation and interim analysis
  • Review and provide inputs to statistical analysis plan and CRF
  • Review tables, listings, figures and clinical study reports
  • Collaborate with internal and external stakeholders (CROs) to resolve issues around statistics
  • Respond to agency queries on issues related to biostatistics

Qualification: MSc., PhD in Biostatistics


Experience: 10-15 years' experience in a Pharma / CRO


Employment Type: Full Time, Permanent

Read full job description

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