Statistical Leadership Role for Complex Studies

5 days ago


Bengaluru, Karnataka, India MUM Fortrea Development India Pvt Ltd Full time

FORTREA, a leading global contract research organization, is seeking a highly skilled Principal Biostatistician to join our FSP team in India.

About the Role

This exciting opportunity involves leading complex studies such as NDA submissions or multi-protocol programs, coordinating activities across multiple locations, and providing statistical oversight. You will be responsible for performing project management activities, including resource planning, timelines, and milestone management.

Key Responsibilities
  • Lead complex studies, including NDA submissions and multi-protocol programs, ensuring timely completion and adherence to quality standards.
  • Perform project management activities, including resource allocation, timeline management, and milestone tracking.
  • Develop and review Statistical Analysis Plans (SAPs) for complex studies, ensuring accuracy and adherence to regulatory requirements.
  • Conduct complex statistical analyses, review CRFs, and other study-specific documents, and provide statistical input for CSR preparation.
  • Mentor and train less experienced staff, providing direction and review of their work to ensure accuracy and adherence to departmental policies and procedures.
Required Skills and Qualifications

To be successful in this role, you will need:

  • M.Sc., M.Phil., or Ph.D. in Statistics or a related field.
  • 7-12 years of experience in biostatistics, with a focus on complex studies and SAP development.
  • Strong understanding of regulatory requirements, including ICH-GCP and FDA regulations.
  • Excellent communication and leadership skills, with the ability to mentor and train staff.
Benefits

We offer a competitive salary package, including a base salary of ₹1,200,000 - ₹1,800,000 per annum, depending on experience, plus benefits and opportunities for professional growth and development.

Fortrea is committed to revolutionizing the drug and device development process, ensuring swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and contribute to making a meaningful global impact.



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