Principal Statistical Strategist

2 weeks ago

Vadodara, Gujarat, India beBeeBiostatistician Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Job Summary:

The Senior Biostatistician is a key member of our clinical development team, responsible for leading and developing statistical strategies to support the success of our R&D sponsored clinical trials. The successful candidate will lead biostatistics efforts for assigned studies and projects, collaborate with cross-functional teams to design and implement statistical analysis plans (SAPs), author and review SAPs, including mock tables, figures, and listings, oversee statistical programming activities and manage deliverables from vendors, provide statistical leadership in regulatory interactions, communicate project status to management, review and provide statistical input for clinical study reports, regulatory documents, and publications, perform quality control (QC) of statistical outputs, and maintain compliance with internal standards.

Main Responsibilities:
  • Lead biostatistics efforts for assigned studies and projects
  • Collaborate with cross-functional teams to design and implement statistical analysis plans (SAPs)
  • Author and review SAPs, including mock tables, figures, and listings
  • Oversee statistical programming activities and manage deliverables from vendors
  • Provide statistical leadership in regulatory interactions and communicate project status to management
  • Review and provide statistical input for clinical study reports, regulatory documents, and publications
  • Perform quality control (QC) of statistical outputs and maintain compliance with internal standards
Requirements:

The ideal candidate should possess a Master's degree or PhD in Biostatistics, Statistics, or related quantitative field. Additionally, minimum 8 years of experience in clinical trial biostatistics for MS-level candidates; minimum 6 years for PhD-level candidates are required. Proficiency in statistical programming in SAS, knowledge of R and other programming languages are preferred. A solid understanding of statistical methodologies and clinical trial designs is essential. Experience with regulatory support and interaction, proven ability to manage multiple studies and timelines concurrently are also necessary.

Working Relationships:

Strong collaboration and communication skills are crucial for this role, with the ability to work effectively with cross-functional teams and external stakeholders.

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