Director of Biostatistics - Clinical Development


Gaithersburg, MD

Industry: Business Services


5 - 7 years

Posted 392 days ago

  by    Branden Lynch

This job is no longer available.

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


DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.


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$160K - $300K