Lead Biostatistics team through study design, statistical analysis, and data reporting for assigned clinical development programs.
*** Serve as subject matter expert in statistical methods and regulatory guidelines set forth by the Pharmaceuticals and Medical Devices Agency, European Medicines Agency, US Food & Drug Administration, Chinese Food and Drug Administration, International Conference on Harmonization, etc.
*** Develop study protocols, case report forms, statistical analysis plans, and sections of clinical study reports, and related registration forms.
*** Guide experimental design, protocol development, sample size estimation, patient randomization, and presentation of data.
*** Prepare Integrated Summaries of Safety and Efficacy.
Ideal candidate will have 5+ years of Statistical Analysis experience focusing on late stage drug development or similar phase in the Pharmaceutical industry.
Scientific leadership role offers a competitive compensation package, bonuses, full medical benefits, 401(k) savings plan, stock options, health and wellness benefits, generous paid vacation time, numerous professional development opportunities, and more!
Please reference #37640202 when responding.Education Requirements: Bachelor DegreeMinimum Experience Requirements: 5-10 yearsJob City Location: GaithersburgJob State Location: MDJob Country Location: USASalary Range: $160,000 to $300,000
WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES:Top 10 Job Site Top 10 Careers Site Biometrics Clinical Research VP Director Senior Scientist Researcher Biostatistics Clinical Data Management Biostatistics Director Senior Clinical Data Manager
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