Senior Biostatistician

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 standards, ADaM, and TFL programming.
• Strong proficiency in statistical software (e.g., SAS, R)
• In-depth knowledge in clinical trial methodology, and regulatory requirement(e.g., FDA, EMA)
• Excellent problem-solving skills and attention to detail.
• Strong Leadership, communication and interpersonal skills.
• Ability to effectively manage multiple tasks and projects
• Ability to clearly describe statistical techniques and interpret results