Experienced Biostatistician (Based in Pune)

				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:

* 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 with pharmaceutical clinical trial experience;
* Strong experience in SAS(r) programming or equivalent;
* Knowledge of other statistical software; 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;
* Excellent verbal and written communication skills
			

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