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Lead Statistician - Clinical Trials

Lead Statistician - Clinical Trials

beBeeBiostatisticianThane, Maharashtra, India
1 day ago
Job description

The Senior Biostatistician spearheads statistical innovation and outcomes in clinical trials. This role contributes to the planning, execution and interpretation of statistical analyses ensuring high-quality, timely deliverables.

  • Acts as biostatistics lead for assigned studies and projects
  • Leverages expertise in study design discussions, including protocol development and sample size estimation
  • Authors Statistical Analysis Plans (SAPs) and oversees statistical programming activities
  • Provides strategic leadership in vendor oversight and communication with management
  • Reviews clinical study reports and regulatory documents for statistical accuracy and compliance
  • Liaises with regulatory authorities on statistical issues and provides applicable strategies
  • Delivers statistical presentations to stakeholders and regulatory authorities as needed

A master's or doctoral degree in Biostatistics, Statistics or a related quantitative field is required. A minimum of 8 years' experience in clinical trial biostatistics for MS-level candidates; a minimum of 6 years for PhD-level candidates.

  • Proficiency in SAS statistical programming. Familiarity with R and other programming languages is beneficial
  • In-depth knowledge of statistical methodologies and clinical trial designs
  • Experience with CDISC standards and regulatory support
  • Demonstrated ability to manage multiple studies concurrently and communicate effectively
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    Clinical Trial Clinical • Thane, Maharashtra, India

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