Lead Clinical Trial Biostatistics Specialist

6 hours ago

Bhavnagar, Gujarat, India beBeeBiostatistician Full time ₹ 30,00,000 - ₹ 35,00,000

We are seeking a highly experienced Senior Biostatistician to lead the development of statistical strategies and deliverables in support of our clinical trials.

Key Responsibilities
  • Oversee biostatistics efforts for assigned studies and projects, ensuring high-quality, timely deliverables that meet regulatory and scientific standards.
  • Contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • Develop and oversee Statistical Analysis Plans (SAPs), including mock tables, figures, and listings.
  • Collaborate with programming and CRO partners to execute statistical analyses per SAP.
  • Provide statistical leadership in vendor oversight, directing statistical programming activities and managing deliverables.
  • Communicate project status to management and escalate issues or risks in a timely manner.
  • Review statistical input and output for clinical study reports, regulatory documents, and publications.
  • Maintain quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards.
  • Support regulatory interactions on statistical issues and provide applicable statistical strategies.
Requirements:
  • A Master's degree or PhD in Biostatistics, Statistics, or related quantitative field.
  • 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 understanding of statistical methodologies and clinical trial designs.
  • Experience with regulatory support and interaction, as well as providing statistical oversight of vendors and managing CRO collaborations.
Benefits

This role offers opportunities for professional growth, collaboration with cross-functional teams, and a dynamic work environment.

About Us

We are committed to fostering a culture of innovation, excellence, and teamwork. Our mission is to make a meaningful impact in the field of clinical research.

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