Chief Statistical Strategist

2 weeks ago

Salem, Tamil Nadu, India beBeeBiostatistician Full time ₹ 1,11,51,300 - ₹ 1,51,47,600

We are seeking a Senior Biostatistician to spearhead statistical strategies and deliverables that support clinical trials.

Key Responsibilities:
  • Lead biostatistics for assigned studies and projects
  • 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
  • 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
  • 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

Requirements:

  • Masters degree or PhD in Biostatistics, Statistics, or related quantitative field required
  • Minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; minimum 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 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
  • Ability to work as a team and have skills to convince your position within cross-functional teams

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