Senior Quantitative Analyst

7 days ago

Gulbarga, Karnataka, India beBeeBiostatistician Full time ₹ 19,03,680 - ₹ 22,44,800
Job Description

The Senior Biostatistician is a key member of our team, responsible for leading and developing statistical strategies and deliverables in support of advanced-clinical's R&D sponsored clinical trials. This role contributes to the planning, execution, and interpretation of statistical analyses across development programs, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.

Key Responsibilities
  • Serve as biostatistics leader for assigned studies and projects
  • Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs)
  • Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners
  • Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
  • Regularly communicate project status to management and escalate issues or risks in a timely manner
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications
  • Perform quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
  • Lead or support regulatory interactions on statistical issues and provide applicable statistical strategies to handle clinical and regulatory considerations
  • Deliver statistical presentations to internal and external stakeholders, or regulatory authorities as needed
  • Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines
Requirements
  • Masters degree or PhD in Biostatistics, Statistics, or related quantitative field, 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. Knowledge of R and other programming languages preferred
  • Solid knowledge of statistical methodologies and clinical trial designs
  • Strong understanding of CDISC standards (e.g., SDTM, ADaM) and their application
  • Experience with regulatory support and interaction
  • Experience providing statistical oversight of vendors and managing CRO collaborations
  • Proven ability to manage multiple studies and timelines concurrently
  • Excellent verbal and written communication skills, with ability to explain statistical concepts to non-statisticians
  • Able to work independently with minimum supervision
Qualifications
  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field
  • 8+ years of experience in clinical trial biostatistics (MS-level) or 6+ years (PhD-level)
  • Proficient in statistical programming using SAS, with knowledge of R and other programming languages
  • Solid knowledge of statistical methodologies and clinical trial designs
  • Strong understanding of CDISC standards and their application
  • Regulatory experience and ability to interact effectively
  • Proven track record of managing multiple studies and timelines
  • Excellent communication and teamwork skills
  • Able to work independently with minimal supervision

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