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 ADa M 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:
Ph D 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 standards, ADa M, and TFL programmi

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