Top 1 Senior statistician Jobs in Frederick Md

Senior Biostatistician
VENESCO, LLC —Fort Detrick, MD
- $145,000 - $165,000 a year
- Full-time
- Doctor of Philosophy
- Mentoring
- Senior level
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Senior Biostatistician

VENESCO, LLC -
Fort Detrick, MD

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Job Details

Full-time
$145,000 - $165,000 a year

Qualifications

Health sciences research
FDA submissions
Biostatistics-based research
ICH guidelines
Doctor of Philosophy
CDISC standards
Regulatory submission editing and review
Communication with regulatory authorities for clinical trials

Full Job Description

Description:

Senior Biostatistician

Venesco LLC is seeking a Senior Biostatistician to provide statistical leadership for clinical and nonclinical studies by designing statistical methodologies, developing analysis plans, interpreting data, and supporting regulatory interactions and submissions.

Requirements:

Duties and Responsibilities

Develop Statistical Analysis Plans (SAPs).
Lead study design and sample size calculations.
Provide statistical oversight of clinical studies.
Review protocols and CRFs.
Develop statistical methodologies and analysis strategies.
Review statistical outputs and interpretation of results.
Support FDA meetings and regulatory submissions.
Respond to statistical questions from regulatory agencies.
Mentor junior statisticians and programmers.
Participate in cross-functional program reviews.

Minimum 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.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.

For more information on Venesco, LLC., visit https://venesco.com.

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