Advanced Quantitative Analyst

17 hours ago

Cochin, Kerala, India beBeeBiostatistician Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

As a key leader in the development and implementation of statistical strategies for clinical trials, this role contributes to planning, execution, and interpretation of statistical analyses across development programs.

Key Responsibilities
  • Leads biostatistical efforts for assigned studies and projects ensuring timely completion and high-quality results.
  • Contributes to study design discussions including protocol development, endpoint definition, and sample size estimation applying advanced statistical methodologies.
  • Develops and reviews Statistical Analysis Plans (SAPs) including mock tables, figures, and listings (TFLs).
  • Oversees statistical analysis execution and collaborates with programming and CRO partners optimizing efficiency and quality control.
  • Provides statistical leadership in vendor oversight and directs statistical programming activities promoting best practices and compliance.
  • Communicates project status to management and escalates issues or risks timely maintaining transparency and accountability.
  • Reviews and provides input on clinical study reports, regulatory documents, and publications.
  • Performs quality control (QC) of statistical outputs to ensure accuracy and compliance adhering to CDISC standards.
  • Leads regulatory interactions on statistical issues and provides applicable statistical strategies supporting business objectives.
Requirements
  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field demonstrating strong academic credentials.
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum 6 years for PhD-level candidates showcasing relevant industry expertise.
  • Proficiency in statistical programming in SAS, knowledge of R and other programming languages preferred.
  • Solid understanding of statistical methodologies and clinical trial designs.
  • Strong knowledge of CDISC standards and their application.
  • Experience with regulatory support and interaction, providing statistical oversight of vendors, and managing CRO collaborations.
  • Ability to manage multiple studies and timelines concurrently ensuring efficient project delivery.
  • Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians.

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