Job Title: Senior Biostatistician

Experience : 6 + yrs

Work Mode : Hybrid / Remote

Location : Across India

Notice Period – Immediate or Less than 30 days only

JOB DESCRIPTION

Key Responsibilities

· Provide statistical input for protocol development, study design, and sample size calculation

· Develop Statistical analysis Plan including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports.

· Collaborate with cross-functional teams including clinical, regulatory, medical writing, and data management

·
Oversee production and quality control of randomization schedules

· Review case report forms and data validation guidelines to ensure quality and integrity of study data collection

· Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards

· Provide statistical input for Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) activities, including development of DSMB/DMC charters and analysis plans,



and serve as an independent statistician providing data and analysis support for DSMB/DMC review

· Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management.

· Ensure compliance with regulatory guidelines and industry standards

· Prepare and review clinical trial reports, and regulatory submissions.

· Mentor and provide guidance to junior statistician or biostatistician and statistical programmer

· Stay updated with advancements in biostatistics and relevant regulatory guidelines

Qualifications:

· PhD in statistics or biostatistics and 4+ years of experience as a biostatistician in CRO or Pharmaceutical companies or Master’s degree in Biostatistics or statistics, or related field and 7+ years of experience as a biostatistician in CRO or Pharmaceutical companies.

· Thoro

📌 Senior Biostatistician (Bengaluru)
🏢 The Whiteboard
📍 Bengaluru