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
