What does a principal biostatistician do?
Principal biostatisticians are professionals who are responsible for communicating all the activities related to biostatistics of assigned projects to the sponsor companies. These biostatisticians are required to participate in the development of finished products used in clinical trials and provide statistical oversight to ensure data integrity and appropriate analysis are performed. They must develop customized statistical programs that can generate statistical data listings, summary tables, and figures. Principal biostatisticians must also answer all the questions from regulatory authorities appropriately.
Principal biostatistician responsibilities
Here are examples of responsibilities from real principal biostatistician resumes:
- Present at investigator meetings for international and domestic sites, CRAs, and country leads.
- Manage qualification, preventative maintenance and calibration of equipment and reagents used in testing as per GLP standards.
- Lead a team of 11 direct reports and 35 indirect reports to solve development problems for multicapillary electrophoresis instruments.
- Provide technical support, measuring run parameters using GC, HPLC, viable cell count, enzyme assays and other protocols.
- Develop and coordinate QC procedures for biometrics' deliverables.
- Answer safety concerns of FDA.
- Supervise testing in GMP environments.
- Participate in writing and reviewing final study reports for NDA submission.
- Ensure GMP compliance and efficiency in all aspects of laboratory operations.
- Invent a modification of the Maxam-Gilbert DNA solid phase sequencing procedure.
- Perform quality control of all TLGs including independent programming QC for topline TLGs.
- Explore new HPLC column technologies for separating novel drug formulations from complex matrices.
- Partner with FDA statisticians during protocol design, analysis and submission phases of submissions.
- Train on IUCAC and ICH principles and ethical use of animals in animal testing process.
- Direct participation in evaluation and editing of DNA sequence data generate by the sequencing hub.
Principal biostatistician skills and personality traits
We calculated that 17% of Principal Biostatisticians are proficient in Clinical Trials, QC, and Statistical Analysis. They’re also known for soft skills such as Analytical skills, Math skills, and Problem-solving skills.
We break down the percentage of Principal Biostatisticians that have these skills listed on their resume here:
- Clinical Trials, 17%
Ensured the periodic Clinical Trial Safety Monitoring reports were prepared and distributed appropriately.
- QC, 12%
Developed and coordinated QC procedures for biometrics' deliverables.
- Statistical Analysis, 12%
Provide monthly and yearly forecasts to sales departments and other statistical analysis to various departments.
- Clinical Study Reports, 9%
Prepared statistical output for distribution to other departments within the Sponsor company to support clinical study reports.
- Statistical Methods, 9%
Advised clinicians, toxicologists, and field veterinarians on statistical methods for field, clinical, and laboratory studies.
- Statistical Reports, 9%
Interact with medical writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information.
Most principal biostatisticians use their skills in "clinical trials," "qc," and "statistical analysis" to do their jobs. You can find more detail on essential principal biostatistician responsibilities here:
Analytical skills. The most essential soft skill for a principal biostatistician to carry out their responsibilities is analytical skills. This skill is important for the role because "mathematicians and statisticians use mathematical techniques and models to evaluate large amounts of data." Additionally, a principal biostatistician resume shows how their duties depend on analytical skills: "partnered with fda statisticians during protocol design, analysis and submission phases of submissions. "
Math skills. Another essential skill to perform principal biostatistician duties is math skills. Principal biostatisticians responsibilities require that "mathematicians and statisticians use statistics, calculus, and linear algebra to develop their models and analyses." Principal biostatisticians also use math skills in their role according to a real resume snippet: "provided annual presentations on biostatistical software and basic biostatistics for residents and staff at chla. "
Problem-solving skills. principal biostatisticians are also known for problem-solving skills, which are critical to their duties. You can see how this skill relates to principal biostatistician responsibilities, because "mathematicians and statisticians must devise solutions to problems encountered in science, engineering, and other fields." A principal biostatistician resume example shows how problem-solving skills is used in the workplace: "support the protocol writing by providing statistical computational solutions for scenarios simulations and sample size calculations.2. "
Communication skills. principal biostatistician responsibilities often require "communication skills." The duties that rely on this skill are shown by the fact that "mathematicians and statisticians must be able to explain technical concepts and solutions in nontechnical ways." This resume example shows what principal biostatisticians do with communication skills on a typical day: "set up a communication system between internal company departments to manage regulatory document collection and review of 450 study sites. "
The three companies that hire the most principal biostatisticians are:
- Edwards Lifesciences99 principal biostatisticians jobs
- Laboratory Corporation of America Holdings85 principal biostatisticians jobs
- QuintilesIMS71 principal biostatisticians jobs
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Compare different principal biostatisticians
Principal biostatistician vs. Statistical consultant
These skill sets are where the common ground ends though. The responsibilities of a principal biostatistician are more likely to require skills like "clinical study reports," "regulatory authorities," "statistical sections," and "cdisc." On the other hand, a job as a statistical consultant requires skills like "statistical data analysis," "regression," "sas/graph," and "spss." As you can see, what employees do in each career varies considerably.
Statistical consultants earn the highest salaries when working in the pharmaceutical industry, with an average yearly salary of $113,929. On the other hand, principal biostatisticians are paid more in the health care industry with an average salary of $125,450.On average, statistical consultants reach similar levels of education than principal biostatisticians. Statistical consultants are 0.2% less likely to earn a Master's Degree and 25.0% less likely to graduate with a Doctoral Degree.Principal biostatistician vs. Biometrician
While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that principal biostatistician responsibilities requires skills like "qc," "clinical study reports," "statistical methods," and "statistical reports." But a biometrician might use other skills in their typical duties, such as, "sas," "forests," "analyze data," and "experimental design."
Biometricians earn lower levels of education than principal biostatisticians in general. They're 7.0% less likely to graduate with a Master's Degree and 25.0% less likely to earn a Doctoral Degree.Principal biostatistician vs. Human resource statistician
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from principal biostatistician resumes include skills like "qc," "clinical study reports," "statistical reports," and "regulatory authorities," whereas a human resource statistician is more likely to list skills in "statistical data," "statistical models," "sas," and "statistical tests. "
Human resource statisticians typically earn higher educational levels compared to principal biostatisticians. Specifically, they're 6.7% more likely to graduate with a Master's Degree, and 33.3% more likely to earn a Doctoral Degree.Principal biostatistician vs. Applied statistician
Types of principal biostatistician
Updated January 8, 2025
