Senior Quantitative Analyst

3 days ago

Kollam, Kerala, India beBeeBiostatistician Full time ₹ 1,80,00,000 - ₹ 2,00,00,000
About Our Senior Biostatistician Role

Our team is seeking an experienced Senior Biostatistician to lead and develop statistical strategies and deliverables in support of our clinical trials.

This role will contribute to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality and timely deliverables that meet regulatory and scientific standards.

Key Responsibilities
  • Serve as biostatistics leader for assigned studies and projects, overseeing the design, implementation, and delivery of statistical strategies.
  • Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation, collaborating with cross-functional teams to ensure alignment and quality.
  • Author and review Statistical Analysis Plans (SAPs), providing clear and concise guidance on mock tables, figures, and listings (TFLs).
  • Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners, ensuring timely and accurate results.
  • Provide statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables, ensuring compliance with internal standards and regulations.
  • Regularly communicate project status to management and escalate issues or risks in a timely manner, fostering a culture of transparency and accountability.
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications, ensuring accuracy and clarity.
  • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards, implementing process improvements as needed.
Requirements
  • A Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field is required.
  • Minimum of 8 years of experience in clinical trial biostatistics for MS-level candidates; Minimum of 6 years for PhD-level candidates.
  • Proficiency in statistical programming in SAS is required, with knowledge of R and other programming languages being preferred.
  • Solid knowledge of statistical methodologies and clinical trial designs is essential, as well as a strong understanding of CDISC standards (e.g., SDTM, ADaM).
  • Experience with regulatory support and interaction, as well as providing statistical oversight of vendors and managing CRO collaborations, is highly valued.
  • Proven ability to manage multiple studies and timelines concurrently, with excellent verbal and written communication skills, is crucial.
  • Able to work independently with minimum supervision and have a strong interest in and ability to learn clinical drug development processes.

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