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 5,900 people across 40+ countries.
Responsibilities:
* Contribute to clinical development plan preparation;
* Review of study protocol and preparation of statistical methodologies;
* Development of detailed Medpace Data Analysis Plan for assigned projects;
* Programming of study analysis, review of study results and preparation of statistical methods section for clinical/statistical reports;
* Communicate project requirements for CRF design, database design and database cleanup to ensure the key study variables are suitable for analysis; and
* Communicate statistical results to medical writing personnel to ensure accurate interpretation.
Qualifications:
* Ph.D. degree in Biostatistics/Statistics;
* Strong experience in SAS(r) programming or equivalent;
* Knowledge of other statistical software;
* Knowledge of advanced statistical methods;
* Knowledge of regulatory requirements/guidelines for drug development;
* Familiarity with complex statistical methods;
* Experience in generation of analysis databases;
* Bilingual English and Japanese.
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