Senior Biostatistician

Description:

Responsible for providing expert biostatistics support for the planning, design, conduct, analysis and reporting of clinical studies. Function as lead biostatistician for clinical projects and coordinate the data analysis activities of other staff members. Responsible for all statistical activities related to clinical studies for feasibility, efficacy, safety, performance and/or clinical claims in accordance with global regulatory requirements.

Responsible for assisting in the preparation of various regulatory submissions, including NDAs, IDEs, PMAs, 510Ks, and domestic & foreign filings. Develop and maintain working relationships with database vendors, site investigators and clinical staff. Help design data displays and reporting formats. Documents results and procedures used in the course of statistical analysis.

Requirements:

	MS or Ph.D. in Statistics or Biostatistics with a minimum 8 years’ related experience in CRO, biotech, or pharma industries
	Familiarity with statistical methodology for Phase I-IV clinical trials
	Strong working knowledge of SAS®, and other statistical applications, regulatory requirements, and some preparation and/or defense of regulatory submissions

To apply for one of the above positions, please submit your résumé or curriculum
vitae (CV) to careers@researchpoint.com

[Back to Top]