Biostatistician's provide valuable information about sample size calculation, develop statistical analysis plan and conduct data analysis.
Biostatisticians closely work with the clinical operations and the medical teams to develop plans about how many study subjects will be enrolled for a study, how the data will be analyzed and how any changes to the study design during the study conduct will be aligned with the statistical analysis plans.
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A career in biostatistics can be very rewarding. Biostatisticians are statisticians who apply their statistics skills and extensive knowledge in health related fields to draw meaningful conclusions from clinical trial data. They collaborate with other researchers in the health discipline, work closely with other clinical research personnel and analyze datasets in pursuit of answers to specific questions. Biostatisticians provide expertise in the planning stages, on data collection, on choosing and implementing appropriate methodologies and interpreting results. Healthcare, biomedical and pharmaceutical fields recruit biostatisticians who are primarily responsible for analyzing genetic, disease occurrence, and medical imaging data. Biostatisticians also help to calculate clinical trial sample size for new studies. Biostatisticians provide statistical consultation to support research and development.
Some common responsibilities of a biostatistician are:
– Writing statistical analysis plans and other statistical sections for clinical trial protocols
– Analyzing clinical trial data and providing analysis reports to medical writers
– Coordinate data acquisition
– Provide broad statistical support throughout the study duration
– Occasionally write SAS program codes
Competencies & Skills:
Various competencies and skills are required to become a Biostatistician. Some of them are:
– Thorough understanding of the drug development process with extensive knowledge of ICH-GCP
– Extensive knowledge of clinical trial regulations such as those of US FDA, EMEA, DCGI etc
– Good computer skills
– Good written and verbal skills
– Problem solving skills
– Time management skills
– Bachelors or Masters degree in Statistics
– Knowledge of SAS Programming
– Knowledge of theoretical statistics and statistics application
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Clinical Data Manager