Summary of Responsibilities:
- Lead complex studies such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight, and attending relevant project meetings.
- Perform project management activities for identified projects including resource planning, timelines, and milestone management.
- Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants.
- Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians.
- Perform complex statistical analyses, quality check statistical analyses developed by other statisticians.
- Conduct overall statistical review of TFLs for complex studies prior to client delivery.
- Review CRF and other study specific specifications and plans.
- Perform complex sample size calculations under the supervision of more senior statistical staff.




- Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant.
- Provide statistic input and review of the CSR for complex studies.
- Preparation and review of randomization specifications and generation of randomization schedules.
- Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
- Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences.
- Attend bid defense meetings for complex studies such as NDA submissions or complex, multiprotocol programs in order to win new business.
- Act as Subject Matter Expert and develop or review procedural documents, or work on recent initiatives.
- Represent the department during audits.
- All other duties as needed or assigned.

Qualifications (Mi

📌 Principal Biostatistican (Bengaluru)
🏢 Fortrea
📍 Bengaluru