Clinical Trial Statistician Leader

6 days ago

Kozhikode, Kerala, India beBeeBiostatistician Full time ₹ 28,00,000 - ₹ 42,00,000
Job Title: Senior Biostatistician Lead

About the Role

The Senior Biostatistician Lead plays a key role in spearheading biostatistical strategies and deliverables to support clinical trials. Working closely with the Head of Biostatistics, this individual contributes to planning, execution, and interpretation of statistical analyses across development programs.

This position requires strong leadership skills to drive high-quality, timely deliverables that meet regulatory and scientific standards.


Responsibilities
  • Lead biostatistics for assigned studies and projects, ensuring seamless collaboration with programming and CRO partners.
  • Contribute to study design discussions, including protocol development, endpoint definition, and sample size estimation.
  • Author and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings (TFLs).
  • Oversee statistical programming activities and manage deliverables from vendors.
  • 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.
  • Collaborate on regulatory interactions and provide applicable statistical strategies for clinical and regulatory considerations.

Requirements
  • A Master's degree or PhD in Biostatistics, Statistics, or a related quantitative field is required.
  • A 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.
  • Proven ability to manage multiple studies and timelines concurrently.

Benefits

This role offers opportunities for growth and professional development in a dynamic environment.

As a team member, you will have access to cutting-edge tools and technologies, as well as ongoing training and education to enhance your skills.


About Us

We are a leading organization in the field of biostatistics and clinical research. Our team is dedicated to delivering high-quality results and making a positive impact on patient lives.

We value our employees' contributions and offer a supportive work environment that fosters collaboration, innovation, and growth.

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