Senior Biostatistician
$145,000–$165,000 year
On-siteFrederick, Maryland, United States
Frederick, Maryland, United StatesOn-siteFull Time$145,000–$165,000 yearSenior LevelDoctorate Or Professional DegreeMedium
Full TimeSenior LevelDoctorate Or Professional DegreeMedium
Job Summary
Design statistical analysis plans and lead study design with sample size calculations for clinical and nonclinical studies. Provide statistical oversight of clinical studies by reviewing protocols and CRFs while developing methodologies and analysis strategies. Interpret results, review statistical outputs, and support FDA meetings and regulatory submissions including responses to agency questions. Mentor junior statisticians and programmers while participating in cross-functional program reviews.
Required Qualifications
- PhD in Biostatistics, Statistics, Epidemiology, or related quantitative science
- Minimum 10 years of biostatistics experience supporting regulated clinical research
- Expertise in ICH E9 Statistical Principles for Clinical Trials
- Experience supporting FDA submissions and regulatory interactions
- Knowledge of CDISC standards and statistical programming environments
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