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 calculationDevelop 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 managementOversee production and quality control of randomization schedulesReview case report forms and data validation guidelines to ensure quality and integrity of study data collectionDesign analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standardsProvide 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 standardsPrepare and review clinical trial reports, and regulatory submissions.Mentor and provide guidance to junior statistician or biostatistician and statistical programmerStay 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 Masters 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 projectsAbility to clearly describe statistical techniques and interpret results 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 calculationDevelop 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 managementOversee production and quality control of randomization schedulesReview case report forms and data validation guidelines to ensure quality and integrity of study data collectionDesign analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standardsProvide 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 standardsPrepare and review clinical trial reports, and regulatory submissions.Mentor and provide guidance to junior statistician or biostatistician and statistical programmerStay 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 Masters 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 projectsAbility to clearly describe statistical techniques and interpret results