Work mode : Hybrid / Remote
Location : Across India
Experience - 6+ yrs
Looking for Immediate Joiner with Biomarker experience

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.
• Thorough knowledge of and experience with CDISC standar

📌 Senior Biostatistician (Chennai)
🏢 ACL Digital
📍 Chennai