Statistical Leader

4 days ago

Jaipur, Rajasthan, India beBeeBiostatistician Full time ₹ 18,00,000 - ₹ 22,00,000
Senior Biostatistician Role

The Senior Biostatistician is a critical member of the clinical trial team, responsible for developing and implementing statistical strategies to ensure high-quality deliverables.

Key Responsibilities:
  • Lead statistical discussions and contribute to study design, including protocol development, endpoint definition, and sample size estimation.
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs).
  • Oversee 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:
  • Master's degree or PhD in Biostatistics, Statistics, or a 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 the 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 minimal supervision.

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