Sr. Manager of Biostatistics
JP-Tokyo
International Careers
Req #: 11360
Type: Full-Time
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Overview: Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities: * Manage the generation of analysis databases, and analyses for medium to high complexity clinical trial projects including ISS, ISE, and electronic submissions; * Assist in the development of new processes for efficient analysis production; * Provide leadership and guidance for solutions in data management, analysis and reporting related issues; * Knowledge of other statistical software; * Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials; * Advise management of relevant new technical developments; and * Eligible to supervise other employees. Qualifications: * Ph.D. degree in Biostatistics/Statistics * 7+ years of pharmaceutical clinical trial experience; * Strong experience in SAS(r) programming or equivalent; * Knowledge of other statistical software; * Knowledge of advanced statistical methods and knowledge of the pharmaceutical industry; * Knowledge of regulatory requirements/guidelines for drug development; * Familiarity with complex statistical methods that apply to Phase I-IV clinical trials; * Experience in generation of analysis databases, and analyses for medium to high complexity clinical trial projects including ISS, ISE, and electronic submissions; * Bilingual English and Japanese.
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