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Associate Director, Biostatistics

Sun Pharma·Gurugram

Pay not stated15–27 yrsFull-timeHybrid

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About the role

Reporting to a Director, Biostatistics Lead, this position will be responsible for supporting the design, execution, analysis and interpretation of registration-directed clinical trials and global regulatory submissions.

What you'll do

  • Serve as study biostatistician on development programs and multiple studies
  • Author statistical analysis plan, TFL shells and other study-related statistical documents
  • Review AdaM Specification , oversee the generation of AdaMs and TFLs and ensure timely high-quality deliverables
  • Plan and implement statistical analyses, provide statistical input to the clinical study report and perform statistical functions for submission-related activities on…
  • Plan and execute exploratory analyses and statistical consultation within applicable cross-functional teams

What you need

  • 15–27 yrs of experience
  • Statistics
  • SAS
  • R
  • Regulatory affairs
  • SOP writing
  • Clinical research
  • PhD

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