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Principal biostatistician skills for your resume and career

Updated January 8, 2025

2 min read

Quoted expert

Rhonda Bacher PhD

Below we've compiled a list of the most critical principal biostatistician skills. We ranked the top skills for principal biostatisticians based on the percentage of resumes they appeared on. For example, 17.4% of principal biostatistician resumes contained clinical trials as a skill. Continue reading to find out what skills a principal biostatistician needs to be successful in the workplace.

15 principal biostatistician skills for your resume and career

1. Clinical Trials

Here's how principal biostatisticians use clinical trials:

Ensured the periodic Clinical Trial Safety Monitoring reports were prepared and distributed appropriately.
Liaised among several major CRO organizations on 7 phase III - IV clinical trials.

2. QC

Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.

Here's how principal biostatisticians use qc:

Developed and coordinated QC procedures for biometrics' deliverables.
Created and maintained standard QC notebooks for clinical research studies.

3. Statistical Analysis

Here's how principal biostatisticians use statistical analysis:

Provide monthly and yearly forecasts to sales departments and other statistical analysis to various departments.
Perform statistical analysis and write reports.

4. Clinical Study Reports

Here's how principal biostatisticians use clinical study reports:

Prepared statistical output for distribution to other departments within the Sponsor company to support clinical study reports.
Developed protocols and prepared clinical study reports.

5. Statistical Methods

Here's how principal biostatisticians use statistical methods:

Advised clinicians, toxicologists, and field veterinarians on statistical methods for field, clinical, and laboratory studies.
Performed subgroup analysis on multiple projects using a wide variety of statistical methods which included Bayesian Analysis.

6. Statistical Reports

Here's how principal biostatisticians use statistical reports:

Interact with medical writers in production of statistical and integrated clinical/statistical reports and other documents containing statistical information.
Analyzed data and wrote statistical reports.

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7. Regulatory Authorities

Regulatory authorities refer to the government organizations created to oversee the policies and procedures enforced in various branches of law. Some examples of these include the Food and Drug Administration, the Federal Trade Commission, and the Bureau of Alcohol, Tobacco, and Firearms. Each of these administrations ensures health and safety regulations put in place by the government are enforced in all appropriate situations.

Here's how principal biostatisticians use regulatory authorities:

Ensured that Questions from regulatory authorities were answered appropriately.
Assisted in the writing of Investigator's Brochure and responses to queries from regulatory authorities.

8. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how principal biostatisticians use fda:

Participated in an End of Phase II meeting with the FDA.
Presented at internal meetings with the FDA Center for Veterinary Medicine.

9. Statistical Support

Here's how principal biostatisticians use statistical support:

Provided statistical support for analyses associated with publications and presentations.
Assumed the responsibility of statistical support to the clinical development programs in major depressive disorder as a project statistician.

10. Statistical Sections

Here's how principal biostatisticians use statistical sections:

Supported Protocol development and wrote down statistical sections of the Protocol.
Lead statistical sections when collaborate with pharmaceuticals/medical device companies on clinical trials.

11. CDISC

Here's how principal biostatisticians use cdisc:

Used CDISC variable standards for phase III drug trial of Black Widow anti-venom.
Analyze CDISC data, and oversee the production and validation of data displays of TLFs.

12. NDA

A non-disclosure agreement, also called a confidentiality agreement, refers to the constitutional paperwork that compels two parties to keep each other's data fully confidential. Trade secrets and different types of sensitive data are kept secure via an NDA. If one party doesn't keep up his end of the bargain, they will break the law and may face charges.

Here's how principal biostatisticians use nda:

Participated in preparation and compilation of NDA submission.
Maintained team focus on NDA submission time lines.

13. Sample Size Calculations

Here's how principal biostatisticians use sample size calculations:

Provide efficacy and safety endpoint measurements and sample size calculations for clinical studies.
Perform sample size calculation using commercial software, such as EAST, PASS.

14. Study Design

Study design entails a detailed framework of data, methods, pathways, procedures, and operations to solve a research problem's variability. These designs come in different forms for different issues, sectors, and fields and aim to find answers and solutions to issues and questions in specific areas.

Here's how principal biostatisticians use study design:

Contributed to study design and developed survey instruments.
Participate in study design and protocol development; Design statistical section of protocol including sample size calculation and power estimation.

15. Biometrics

Here's how principal biostatisticians use biometrics:

Participate in Biometrics sales and marketing efforts.
Represent biometrics at the CTT and GPT meetings.

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What skills help Principal Biostatisticians find jobs?

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What principal biostatistician skills would you recommend for someone trying to advance their career?

Rhonda Bacher PhD

Assistant Professor, University of Florida

In terms of biostatistical skills, techniques for analyzing longitudinal biomedical data are increasingly relevant. Artificial intelligence models are likely to be helpful for programming across languages and tools (e.g. R, Python, TensorFlow), and the next generation of biostatisticians will be in a great position to leverage AI tools to their full potential. On the other side of that, understanding and contributing to AI tool development is an area that biostatisticians can play important roles, especially in the fields of bioinformatics and genomics.

Do you want to know more?

List of principal biostatistician skills to add to your resume

The most important skills for a principal biostatistician resume and required skills for a principal biostatistician to have include:

Clinical Trials
QC
Statistical Analysis
Clinical Study Reports
Statistical Methods
Statistical Reports
Regulatory Authorities
FDA
Statistical Support

Statistical Sections
CDISC
NDA
Sample Size Calculations
Study Design
Biometrics
Cros
Analysis Results
Statistical Aspects

EU
Statistical Issues
Clinical Development Plan
Statistical Research
Primary Endpoint
R
Clinical Development

Updated January 8, 2025

Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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