Clinical Trials Lead

1 week ago

Nellore, Andhra Pradesh, India beBeeBiostatistician Full time ₹ 15,00,000 - ₹ 25,00,000

Senior Biostatistician - Clinical Trial Expert

About the Role

We are seeking a seasoned Senior Biostatistician to join our team and lead the advancement of clinical trials in the biotech industry. As a pivotal member of our R&D department, you will spearhead statistical strategies and deliverables that drive innovation and excellence.

Key Responsibilities
  • Serve as biostatistics leader for assigned studies and projects, ensuring high-quality results that meet regulatory and scientific standards.
  • Lead or contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation, utilizing expertise in statistical methodologies and clinical trial designs.
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings, to ensure compliance with internal standards.
  • Oversee and ensure the execution of statistical analyses per SAP in collaboration with programming and CRO partners, leveraging proficiency in statistical programming in SAS and knowledge of R.
  • Provide statistical leadership in vendor oversight, including directing statistical programming activities and managing deliverables, ensuring timely completion and accuracy.
  • Regularly communicate project status to management and escalate issues or risks in a timely manner, utilizing excellent verbal and written communication skills.
  • Provide statistical input and review for clinical study reports, regulatory documents, and publications, demonstrating ability to communicate complex statistical concepts effectively.
  • 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, showcasing expertise in clinical drug development processes.
  • Contribute to the development, review, and maintenance of statistical standard operating procedures (SOPs), Working Instructions (WIs), and internal guidelines, staying current with emerging statistical methodologies and evolving clinical trial practices.
Required Qualifications
  • Master's degree or PhD in Biostatistics, Statistics, or related quantitative field.
  • 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 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 minimum supervision.

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