Senior Biostatistics Leader — PK & Clinical Trials

Worldwide; Triangle, Northern (VA, KY); Hybrid; USD 97,000 - 192,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Principal Scientist, Biostatistician to lead statistical analyses and study design for clinical programs in the United States. You will drive independent judgment on PK/clinical analyses, interpret results, and contribute to publications and intellectual property while guiding cross‑functional project teams.

The role emphasizes leadership in statistical design, adherence to GLP and FDA guidelines, and collaboration with biopsy, clinical, and marketing

Qualifications

• PhD or postgraduate degree with a scientific focus preferred.
• Bachelor’s degree with a scientific focus and 12 or more years of relevant work experience required.
• Promotion to the next level is not automatic based on years of experience.

Responsibilities

• Design clinical studies and construct data analysis plans to meet study protocol requirements.
• Perform statistical analyses on clinical and pharmacokinetic data using appropriate methods and software programs.
• Prepare documentation for final reports, including text, tables, graphs, and analysis outputs.
• Interact with clients, bioanalytical personnel, and clinical personnel regarding study design, statistical analyses, pharmacokinetic data analyses, and data interpretation.

Skills

SAS programming

Education

PhD or postgraduate degree preferred

Bachelor’s degree + 12+ years experience

Tools

WinNonlin

nQuery

Microsoft Word

Microsoft Excel

Job description

Worldwide Clinical Trials is seeking a Principal Scientist, Biostatistician to lead statistical analyses and study design for clinical programs in the United States. You will drive independent judgment on PK/clinical analyses, interpret results, and contribute to publications and intellectual property while guiding cross‑functional project teams.

The role emphasizes leadership in statistical design, adherence to GLP and FDA guidelines, and collaboration with biopsy, clinical, and marketing