Data Science Leader

3 days ago

Nashik, Maharashtra, India beBeeStatistical Full time ₹ 17,60,000 - ₹ 25,10,000
Job Title:

Senior Biostatistician

Job Summary:

The Senior Biostatistician leads the development, implementation, and oversight of statistical strategies and deliverables in support of clinical trials. This role contributes to planning, execution, and interpretation of statistical analyses across development programs.

Key Responsibilities:
  • Serves as biostatistics leader for assigned studies and projects
  • Leads or contributes to study design discussions, including protocol development, endpoint definition, and sample size estimation
  • Authors and reviews Statistical Analysis Plans (SAPs), including mock tables, figures, and listings
  • Oversees and ensures the execution of statistical analyses per SAP in collaboration with programming and CRO partners
  • Provides statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables
  • Regularly communicates project status to management and escalates issues or risks in a timely manner
  • Provides statistical input and review for clinical study reports, regulatory documents, and publications
  • Performs quality control (QC) of statistical outputs to ensure accuracy and compliance with internal standards
  • Leads or supports regulatory interactions on statistical issues and provides applicable statistical strategies to handle clinical and regulatory considerations
  • Delivers statistical presentations to internal and external stakeholders, or regulatory authorities as needed
  • Contributes to the development, review, and maintenance of statistical standard operating procedures (SOPs), working instructions (WIs), and internal guidelines
  • Stays current with emerging statistical methodologies and evolving clinical trial practices
  • Perform other duties/tasks as required or assigned
Requirements:
  • Master's 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 is 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 timeline 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
  • Demonstrated ability to communicate statistical concepts and results clearly and effectively
  • Interest in and ability to learn clinical drug development processes
  • Able to work independently with minimum supervision

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