Senior Quantitative Analyst

4 days ago

Thrissur, Kerala, India beBeeBiostatistician Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Biostatistical Leadership Role

The incumbent leads the development, implementation and oversight of statistical strategies in support of clinical trials.

  • Serves as biostatistics leader for assigned studies and projects;
  • Leads study design discussions including protocol development, endpoint definition and sample size estimation;
  • Authors and reviews Statistical Analysis Plans (SAPs), including mock tables, figures and listings;
  • Oversight of statistical programming activities and delivery of statistical outputs;
  • Statistical leadership in vendor oversight and direction of statistical programming activities;
  • Regularly communicates project status to management and escalates issues or risks;
  • Provides statistical input and review for clinical study reports, regulatory documents and publications;
  • Ensures quality control of statistical outputs for accuracy and compliance with internal standards.
Requirements
  • A Master's degree or PhD in Biostatistics, Statistics or a related quantitative field is required;
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 6 years for PhD-level candidates are required;
  • Proficiency in statistical programming in SAS is necessary; Knowledge of R and other programming languages is an asset;
  • A solid knowledge of statistical methodologies and clinical trial designs is essential;
  • A strong understanding of CDISC standards and their application is required;
  • Experience with regulatory support and interaction is desirable.

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